CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Automated Impella Controller (AIC) recalled by Abiomed
Abiomed is recalling Automated Impella Controller (AIC) with the below product descriptions and corresponding, distributed nationwide in the US. The recall was initiated on 19 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3251-2026
- FDA event ID
- 99747
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Feb 2019
- FDA classified
- 21 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Potency & Assay
- Device type
- Heart & Vascular Devices
Timeline
| 19 Feb 2019 | Recall initiated by company | |
| 21 Sep 2026 | Classified by FDA | +2771 days |
| 30 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
Where it was distributed
Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
Questions about this recall
Why was it recalled?
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
Which lots are affected?
1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Number: IC2687. 2. Product Code: 0042-0000-EU. GTIN: 00813502011289. Serial Numbers: IC3875, IC2380, IC2331, IC1721, IC1593, IC1587, IC4911, IC4231, IC4232, IC6844, IC2221, IC4628, IC6474, IC4502, IC1398, IC4055, IC3816, IC6810, IC6812, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6272, IC6149, IC6081, IC5681, IC5682, IC5517, IC5177, IC5169, IC5086, IC4892, IC4852, IC4848, IC4875, IC4851, IC4869, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4793, IC4795, IC4792, IC4794, IC4763, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4678, IC4677, IC4646, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4613, IC4614, IC4568, IC4610, IC4612, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4505, IC4506, IC4500, IC4469, IC4466, IC4467, IC4468, IC4446, IC4442, IC4443, IC4444, IC4445, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4328, IC4234, IC4363, IC4362, IC4356, IC4357, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4240, IC4241, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4217, IC4148, IC4149, IC4146, IC4147, IC4128, IC4129, IC4096, IC4097, IC4098, IC4083, IC4036, IC4037, IC3889, IC3833, IC3834, IC3859, IC3861, IC3862, IC3863, IC3885, IC3886, IC3884, IC3871, IC3872, IC3873, IC3832, IC3860, IC3831, IC3830, IC3815, IC3813, IC3814, IC3781, IC3782, IC3708, IC3717, IC3706, IC3707, IC3701, IC3703, IC3709, IC3667, IC3495, IC3492, IC3493, IC3659, IC3490, IC3660, IC3484, IC3485, IC3477, IC3472, IC3461, IC3467, IC3466, IC3468, IC3458, IC3459, IC3330, IC3460, IC3323, IC3313, IC3319, IC3327, IC3328, IC3303, IC3324, IC3321, IC3322, IC3310, IC3315, IC3314, IC3316, IC3304, IC3305, IC3302, IC3301, IC3300, IC3299, IC3297, IC3298, IC3290, IC3292, IC3289, IC3286, IC3288, IC3287, IC3180, IC3181, IC3178, IC3179, IC3145, IC3146, IC3144, IC3143, IC3149, IC3147, IC3148, IC3142, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3095, IC3096, IC3068, IC3067, IC3053, IC3054, IC3051, IC3052, IC3019, IC3017, IC2988, IC2987, IC2984, IC2985, IC2878, IC2960, IC2962, IC2964, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2824, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2708, IC2752, IC2670, IC2659, IC2658, IC2512, IC2556, IC2534, IC2491, IC2484, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2332, IC2412, IC2330, IC2411, IC2326, IC2327, IC2242, IC2325, IC2267, IC2268, IC2241, IC2266, IC2243, IC2204, IC2207, IC2240, IC2231, IC2173, IC2174, IC2171, IC2172, IC2095, IC2098, IC2096, IC2038, IC2039, IC2005, IC2006, IC1975, IC1976, IC1972, IC1973, IC1904, IC1907, IC1901, IC1881, IC1775, IC1780, IC1726, IC1761, IC1653, IC1411, IC1350, IC1383, IC1344, IC1345, IC1288, IC1275, IC1265. 3. Product Code: 0042-0000-UK. GTIN: 00813502011296. Serial Numbers: IC1494, IC3785, IC3784. 4. Product Code: 0042-0000-US. GTIN: 00813502010022. Serial Numbers: IC7027, IC7030, IC7032, IC6931, IC6930, IC6932, IC6929, IC6928, IC6923, IC6919, IC6920, IC6921, IC6922, IC6898, IC6897, IC6917, IC6916, IC6889, IC6894, IC6895, IC6893, IC6901, IC6909, IC6911, IC6910, IC6912, IC6908, IC6913, IC6896, IC6899, IC6900, IC6842, IC6840, IC6836, IC6829, IC6831, IC6832, IC6811, IC6774, IC6864, IC6830, IC6801, IC6800, IC6798, IC6799, IC6847, IC6771, IC6772, IC6850, IC6851, IC6852, IC6854, IC6822, IC6820, IC6819, IC6818, IC6767, IC6754, IC6743, IC6729, IC6725, IC6724, IC6722, IC6682, IC6679, IC6685, IC6674, IC6668, IC6667, IC6647, IC6645, IC6646, IC6639, IC6630, IC6624, IC6625, IC6619, IC6616, IC6613, IC6612, IC6602, IC6601, IC6600, IC6571, IC6568, IC6566, IC6567, IC6565, IC6562, IC6547, IC6546, IC6524, IC6522, IC6518, IC6521, IC6514, IC6511, IC6505, IC6507, IC6504, IC6500, IC6501, IC6497, IC6498, IC6448, IC6495, IC6496, IC6428, IC6445, IC6484, IC6483, IC6438, IC6433, IC6479, IC6471, IC6472, IC6473, IC6470, IC6455, IC6454, IC6427, IC6426, IC6444, IC6450, IC6415, IC6412, IC6414, IC6411, IC6408, IC6409, IC6410, IC6404, IC6403, IC6402, IC6400, IC6401, IC6398, IC6399, IC6045, IC6391, IC6396, IC6392, IC6390, IC6393, IC6394, IC6361, IC6362, IC6368, IC6366, IC6367, IC6369, IC6365, IC6363, IC6364, IC6355, IC6356, IC6295, IC6288, IC6354, IC6352, IC6353, IC6349, IC6335, IC6346, IC6328, IC6329, IC6326, IC6327, IC6325, IC6323, IC6324, IC6319, IC6320, IC6317, IC6318, IC1250, IC6095, IC6271, IC6269, IC6255, IC6266, IC6267, IC6251, IC6250, IC6247, IC6248, IC6249, IC6244, IC6245, IC6246, IC6243, IC6242, IC6241, IC6239, IC6220, IC6218, IC6219, IC6217, IC6198, IC6199, IC6195, IC6196, IC6194, IC6192, IC6190, IC6191, IC6186, IC6187, IC6188, IC6189, IC6184, IC6185, IC6182, IC6183, IC6180, IC6181, IC6179, IC6177, IC6178, IC6176, IC6156, IC6161, IC6159, IC6160, IC6157, IC6158, IC6155, IC6154, IC6153, IC6152, IC6141, IC6144, IC6145, IC6146, IC6143, IC6133, IC6134, IC6136, IC6142, IC6140, IC6115, IC5565, IC6138, IC6137, IC6135, IC6129, IC6130, IC6131, IC6132, IC6128, IC6105, IC6106, IC6107, IC6103, IC6104, IC6100, IC6101, IC6102, IC6099, IC6097, IC6098, IC6092, IC6093, IC6094, IC6096, IC6077, IC6059, IC6063, IC6062, IC6061, IC6056, IC6057, IC6054, IC6055, IC6053, IC6051, IC6052, IC6041, IC6043, IC6044, IC6039, IC6040, IC6035, IC6036, IC6037, IC6034, IC6000, IC6031, IC6032, IC6028, IC6030, IC6033, IC6026, IC6027, IC6002, IC6003, IC6004, IC5992, IC5994, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, IC5981, IC5982, IC5979, IC5977, IC5978, IC5976, IC5954, IC5953, IC5952, IC5951, IC5950, IC5949, IC5947, IC5948, IC5946, IC5945, IC5943, IC5939, IC5940, IC5942, IC5906, IC5895, IC5893, IC5891, IC5892, IC5894, IC5890, IC5843, IC5889, IC5888, IC5881, IC5882, IC5883, IC5886, IC5887, IC5884, IC5885, IC5880, IC5778, IC5599, IC5776, IC5879, IC5874, IC5872, IC5873, IC5875, IC5878, IC5876, IC5877, IC5871, IC5870, IC5858, IC5855, IC5856, IC5857, IC5852, IC5848, IC5849, IC5850, IC5851, IC5847, IC5844, IC5845, IC5839, IC5840, IC5841, IC5842, IC5816, IC5827, IC5828, IC5823, IC5792, IC5793, IC5791, IC5790, IC5789, IC5787, IC5773, IC5770, IC5767, IC5766, IC5765, IC5763, IC5764, IC5760, IC5761, IC5747, IC5745, IC5746, IC5742, IC5743, IC5737, IC5738, IC5739, IC5736, IC5726, IC5723, IC5719, IC5711, IC5710, IC5707, IC5708, IC5704, IC5698, IC5697, IC5692, IC5691, IC5598, IC5663, IC5664, IC5676, IC5678, IC5619, IC5620, IC5564, IC5607, IC5650, IC5655, IC5647, IC5617, IC5615, IC5602, IC5562, IC5610, IC5604, IC5244, IC5552, IC5547, IC5548, IC5544, IC5540, IC5541, IC5539, IC5536, IC4556, IC5498, IC5499, IC5500, IC5503, IC5485, IC5480, IC5479, IC5475, IC4888, IC4889, IC4697, IC4573, IC4517, IC5469, IC5459, IC5470, IC5458, IC5457, IC4558, IC4498, IC4854, IC4935, IC5454, IC5092, IC4481, IC5453, IC5425, IC5420, IC4424, IC5395, IC5394, IC5417, IC5393, IC4584, IC5388, IC4554, IC4515, IC4426, IC5386, IC4922, IC4923, IC4827, IC5375, IC4427, IC4428, IC5374, IC4555, IC5373, IC5372, IC4862, IC4863, IC4574, IC4545, IC5371, IC4510, IC5003, IC4785, IC4786, IC4532, IC5365, IC5366, IC5367, IC5368, IC5369, IC5364, IC4544, IC4541, IC4686, IC4282, IC5345, IC5358, IC5359, IC5360, IC5361, IC5362, IC5363, IC4513, IC4283, IC5342, IC5343, IC5344, IC5340, IC5339, IC4477, IC5338, IC4550, IC4456, IC4415, IC4487, IC4423, IC4495, IC4378, IC4534, IC5337, IC4522, IC4486, IC4494, IC4461, IC4454, IC4431, IC4435, IC4436, IC4379, IC5336, IC5330, IC5335, IC5327, IC5328, IC5332, IC5329, IC5333, IC5334, IC4530, IC4453, IC4422, IC5320, IC5325, IC5324, IC5326, IC5322, IC5323, IC5321, IC4420, IC4336, IC5319, IC5318, IC4535, IC4490, IC4473, IC5313, IC5316, IC5317, IC5311, IC5312, IC5305, IC5304, IC5308, IC5306, IC5242, IC5303, IC5307, IC5310, IC5309, IC5299, IC5300, IC5301, IC5302, IC4472, IC4430, IC4434, IC5271, IC5297, IC5298, IC5293, IC5295, IC5296, IC4694, IC4543, IC4489, IC4474, IC5289, IC5287, IC5288, IC5275, IC5274, IC4526, IC5270, IC5269, IC5272, IC5273, IC4523, IC5266, IC5264, IC5265, IC5267, IC5268, IC4552, IC4540, IC4524, IC4520, IC4476, IC4455, IC4920, IC4804, IC4596, IC4539, IC4509, IC4460, IC5262, IC5263, IC4921, IC4458, IC4974, IC4980, IC4903, IC4485, IC4459, IC4457, IC5221, IC5222, IC5225, IC5172, IC5206, IC5170, IC5192, IC4981, IC4975, IC4696, IC4661, IC4665, IC4604, IC4551, IC4480, IC4432, IC4267, IC5190, IC5191, IC4899, IC4670, IC4536, IC4463, IC3644, IC3592, IC3594, IC4399, IC4408, IC4407, IC4403, IC3825, IC3350, IC3170, IC2869, IC2631, IC2634, IC2465, IC2487, IC1802, IC1830, IC1812, IC1425, IC3923, IC3254, IC2569, IC2580, IC1426, IC1261, IC5188, IC5189, IC4409, IC4402, IC4401, IC4274, IC3792, IC3348, IC3275, IC2781, IC2590, IC2579, IC2516, IC2075, IC1864, IC1814, IC1789, IC1705, IC1674, IC1431, IC1196, IC4828, IC4826, IC4499, IC5208, IC5209, IC3336, IC3272, IC3219, IC3250, IC2870, IC5204, IC5203, IC5207, IC5205, IC4970, IC4977, IC4900, IC4811, IC4674, IC4538, IC3117, IC1756, IC1704, IC4496, IC4497, IC5202, IC5200, IC5198, IC5199, IC5196, IC5197, IC5168, IC5150, IC5166, IC5167, IC5024, IC5155, IC5153, IC5154, IC5151, IC5152, IC5148, IC5149, IC5052, IC5124, IC5125, IC5146, IC5147, IC5123, IC5119, IC5093, IC5094, IC5122, IC5095, IC5116, IC5090, IC5070, IC5072, IC5091, IC5069, IC5063, IC5059, IC5060, IC5054, IC5058, IC4807, IC5074, IC5067, IC5062, IC5061, IC5017, IC5018, IC5005, IC5002, IC4999, IC5019, IC4997, IC4998, IC4994, IC4993, IC4991, IC4990, IC4989, IC4982, IC4475, IC4575, IC4972, IC4969, IC4983, IC4978, IC4979, IC4956, IC4971, IC4967, IC4964, IC4966, IC4962, IC4963, IC4941, IC4943, IC4940, IC4942, IC4938, IC4939, IC4936, IC4937, IC4924, IC4925, IC4918, IC4919, IC4906, IC4907, IC4908, IC4909, IC4904, IC4905, IC4519, IC4902, IC4245, IC4898, IC4896, IC4897, IC4894, IC4895, IC4893, IC4890, IC4886, IC4887, IC4861, IC4884, IC4885, IC4865, IC4864, IC4859, IC4860, IC4858, IC4829, IC4830, IC4825, IC4814, IC4812, IC4813, IC4805, IC4806, IC4802, IC4803, IC4808, IC4809, IC4799, IC4798, IC4789, IC4788, IC4770, IC4769, IC4768, IC4766, IC4767, IC4764, IC4765, IC4755, IC4756, IC4754, IC4752, IC4753, IC4719, IC4720, IC4702, IC4698, IC4699, IC4692, IC4695, IC4693, IC4684, IC4685, IC4668, IC4666, IC4662, IC4660, IC4639, IC4638, IC4603, IC4580, IC4571, IC4593, IC4548, IC4546, IC4547, IC4527, IC4531, IC4529, IC4521, IC4511, IC4512, IC4491, IC4492, IC4483, IC4484, IC4479, IC4493, IC4478, IC4462, IC4437, IC4433, IC4416, IC4417, IC4414, IC4413, IC4411, IC4412, IC4410, IC4390, IC4406, IC4400, IC4398, IC4395, IC4396, IC4392, IC4391, IC4389, IC4386, IC4387, IC4381, IC4382, IC4383, IC4380, IC4376, IC4375, IC4377, IC4373, IC4374, IC4372, IC4351, IC4352, IC4353, IC4354, IC4350, IC4349, IC4348, IC4346, IC4347, IC4345, IC4344, IC4341, IC4342, IC4343, IC4340, IC4339, IC4337, IC4333, IC4320, IC4321, IC4317, IC4318, IC4314, IC4313, IC4311, IC4312, IC4309, IC4310, IC4306, IC4305, IC4304, IC4302, IC4303, IC4301, IC4300, IC4299, IC4298, IC4297, IC4295, IC4293, IC4294, IC4290, IC4291, IC4284, IC4285, IC4280, IC4281, IC4279, IC4278, IC4276, IC4275, IC4273, IC4270, IC4271, IC4263, IC4269, IC4268, IC4265, IC4266, IC4262, IC4264, IC4260, IC4261, IC4259, IC4250, IC4248, IC4247, IC4249, IC4246, IC4243, IC4244, IC4225, IC4226, IC4223, IC4224, IC4221, IC4222, IC4219, IC4220, IC4203, IC4204, IC4205, IC4206, IC4201, IC4202, IC4200, IC4198, IC4196, IC4197, IC4194, IC4195, IC4192, IC4191, IC4174, IC4172, IC4173, IC4170, IC4171, IC4169, IC4167, IC4168, IC4165, IC4163, IC4164, IC4159, IC4136, IC4111, IC4115, IC4112, IC4113, IC4103, IC4104, IC4084, IC4085, IC4076, IC4071, IC4072, IC4073, IC4040, IC4038, IC4039, IC4030, IC4031, IC4029, IC4020, IC4021, IC4016, IC4011, IC4008, IC4005, IC4003, IC3998, IC3999, IC3997, IC4000, IC4001, IC3995, IC3996, IC3994, IC3993, IC3990, IC3986, IC3984, IC3982, IC3985, IC3987, IC3983, IC3980, IC3981, IC3979, IC3973, IC3974, IC3971, IC3972, IC3969, IC3970, IC3899, IC3968, IC3966, IC3967, IC3963, IC3962, IC3960, IC3959, IC3957, IC3958, IC3865, IC3954, IC3955, IC3956, IC3952, IC3953, IC3950, IC3951, IC3948, IC3949, IC3947, IC3946, IC3945, IC3940, IC3944, IC3943, IC3941, IC3942, IC3939, IC3937, IC3938, IC3935, IC3933, IC3934, IC3931, IC3932, IC3928, IC3926, IC3927, IC3929, IC3930, IC3924, IC3925, IC3919, IC3920, IC3915, IC3916, IC3917, IC3918, IC3913, IC3914, IC3912, IC3909, IC3910, IC3911, IC3907, IC3908, IC3906, IC3904, IC3902, IC3903, IC3900, IC3901, IC3897, IC3898, IC3895, IC3896, IC3893, IC3894, IC3892, IC3883, IC3879, IC3880, IC3881, IC3882, IC3876, IC3877, IC3878, IC3858, IC3854, IC3855, IC3856, IC3857, IC3852, IC3853, IC3851, IC3850, IC3849, IC3848, IC3846, IC3847, IC3838, IC3839, IC3835, IC3826, IC3820, IC3821, IC3819, IC3811, IC3808, IC3809, IC3807, IC3804, IC3799, IC3800, IC3801, IC3798, IC3796, IC3797, IC3794, IC3795, IC3793, IC3791, IC3790, IC3787, IC3788, IC3789, IC3774, IC3775, IC3772, IC3773, IC3770, IC3771, IC3768, IC3769, IC3753, IC3754, IC3752, IC3750, IC3749, IC3748, IC3746, IC3747, IC3741, IC3744, IC3745, IC3742, IC3743, IC3740, IC3736, IC3737, IC3738, IC3739, IC3735, IC3734, IC3733, IC3729, IC3730, IC3732, IC3725, IC3726, IC3727, IC3728, IC3714, IC3715, IC3712, IC3713, IC3694, IC3695, IC3710, IC3711, IC3693, IC3690, IC3688, IC3685, IC3680, IC3681, IC3679, IC3650, IC3649, IC3647, IC3648, IC3645, IC3646, IC3643, IC3641, IC3642, IC3638, IC3636, IC3637, IC3635, IC3634, IC3632, IC3633, IC3628, IC3629, IC3627, IC3626, IC3564, IC3610, IC3622, IC3623, IC3624, IC3625, IC3603, IC3601, IC3602, IC3599, IC3600, IC3595, IC3596, IC3529, IC3589, IC3590, IC3581, IC3582, IC3609, IC3579, IC3580, IC3577, IC3578, IC3574, IC3572, IC3567, IC3568, IC3561, IC3557, IC3547, IC3548, IC3544, IC3542, IC3530, IC3528, IC3516, IC3517, IC3520, IC3521, IC3507, IC3508, IC3504, IC3505, IC3506, IC3502, IC3503, IC3499, IC3446, IC3447, IC3443, IC3444, IC3439, IC3437, IC3438, IC3434, IC3432, IC3428, IC3427, IC3426, IC3421, IC3422, IC3419, IC3415, IC3416, IC3417, IC3418, IC3410, IC3411, IC3408, IC3409, IC3406, IC3407, IC3378, IC3379, IC3404, IC3405, IC3354, IC3401, IC3399, IC3400, IC3394, IC3396, IC3397, IC3346, IC3284, IC3386, IC3388, IC3390, IC3384, IC3385, IC3380, IC3381, IC3382, IC3383, IC3371, IC3372, IC3373, IC3283, IC3285, IC3269, IC3369, IC3370, IC3376, IC3377, IC3374, IC3375, IC3367, IC3368, IC3366, IC3361, IC3362, IC3365, IC3363, IC3364, IC3358, IC3359, IC3360, IC3357, IC3355, IC3356, IC3352, IC3353, IC3345, IC3343, IC3337, IC3338, IC3339, IC3340, IC3281, IC3282, IC3341, IC3278, IC3279, IC3277, IC3274, IC3276, IC3270, IC3065, IC3066, IC3271, IC3273, IC3064, IC3268, IC3267, IC3263, IC3266, IC3262, IC3261, IC3257, IC3259, IC3260, IC3258, IC3253, IC3255, IC3215, IC3216, IC3214, IC3217, IC3221, IC3222, IC3218, IC3220, IC3169, IC3185, IC3171, IC3172, IC3176, IC3177, IC3249, IC3251, IC3252, IC3168, IC3248, IC3246, IC3245, IC3247, IC3244, IC3242, IC3243, IC3237, IC3238, IC3239, IC3236, IC3235, IC3233, IC3234, IC3229, IC3230, IC3231, IC3232, IC3224, IC3225, IC3226, IC3212, IC3227, IC3228, IC3207, IC3208, IC3209, IC3211, IC3204, IC3205, IC3206, IC3201, IC3202, IC3203, IC3199, IC3200, IC3198, IC3196, IC3197, IC3193, IC3194, IC3188, IC3189, IC3192, IC3186, IC3187, IC3163, IC3162, IC3164, IC3165, IC3158, IC3159, IC3156, IC3157, IC3152, IC3153, IC3151, IC3139, IC3136, IC3137, IC2978, IC3135, IC3125, IC3126, IC3121, IC3122, IC3123, IC3119, IC3111, IC3113, IC3114, IC3115, IC3118, IC3110, IC3109, IC3108, IC3105, IC3106, IC3103, IC3104, IC3091, IC3092, IC3093, IC3094, IC3089, IC3090, IC3087, IC3086, IC3083, IC3084, IC3085, IC3082, IC2928, IC2791, IC2499, IC3079, IC3080, IC3077, IC3078, IC3075, IC3076, IC3071, IC3072, IC3073, IC3074, IC3062, IC3060, IC3061, IC3058, IC3059, IC3056, IC3055, IC3046, IC3044, IC3045, IC3042, IC3040, IC3041, IC3039, IC3038, IC3036, IC3034, IC3032, IC3033, IC3031, IC3028, IC3029, IC3026, IC3027, IC3030, IC3024, IC3025, IC3023, IC3013, IC3007, IC3008, IC3009, IC3010, IC3006, IC3005, IC3003, IC3004, IC3001, IC3002, IC2999, IC3000, IC2998, IC2995, IC2992, IC2994, IC2990, IC2991, IC2983, IC2993, IC2979, IC2980, IC2974, IC2975, IC2976, IC2977, IC2973, IC2972, IC2969, IC2970, IC2965, IC2966, IC2955, IC2956, IC2951, IC2952, IC2945, IC2946, IC2947, IC2948, IC2731, IC2940, IC2936, IC2937, IC2924, IC2922, IC2926, IC2918, IC2919, IC2920, IC2917, IC2915, IC2916, IC2749, IC2907, IC2901, IC2898, IC2889, IC2885, IC2886, IC2883, IC2881, IC2882, IC2868, IC2865, IC2866, IC2863, IC2848, IC2844, IC2845, IC2832, IC2833, IC2813, IC2822, IC2807, IC2821, IC2819, IC2820, IC2795, IC2796, IC2792, IC2793, IC2794, IC2789, IC2784, IC2786, IC2787, IC2780, IC2772, IC2773, IC2768, IC2761, IC2719, IC2759, IC2760, IC2744, IC2745, IC2746, IC2742, IC2748, IC2739, IC2738, IC2727, IC2729, IC2728, IC2725, IC2726, IC2722, IC2498, IC2408, IC2410, IC2717, IC2718, IC2714, IC2715, IC2716, IC2713, IC2703, IC2700, IC2701, IC2698, IC2699, IC2694, IC2696, IC2697, IC2321, IC2120, IC2690, IC2689, IC2674, IC2681, IC2675, IC2680, IC2671, IC2672, IC2666, IC2667, IC2664, IC2665, IC2648, IC2649, IC2647, IC2646, IC2643, IC2644, IC2662, IC2663, IC2650, IC2651, IC2660, IC2661, IC2638, IC2640, IC2641, IC2636, IC2637, IC2635, IC2632, IC2633, IC2615, IC2616, IC2618, IC2619, IC2620, IC2622, IC2612, IC2613, IC2611, IC2605, IC2608, IC2603, IC2604, IC2601, IC2602, IC2600, IC2599, IC2597, IC2598, IC2217, IC2218, IC2506, IC2594, IC2595, IC2596, IC2593, IC2591, IC2592, IC2587, IC2589, IC2584, IC2581, IC2582, IC2578, IC2576, IC2577, IC2574, IC2572, IC2573, IC2570, IC2567, IC2568, IC2563, IC2564, IC2555, IC2554, IC2552, IC2553, IC2551, IC2524, IC2550, IC2548, IC2543, IC2544, IC2468, IC2495, IC2480, IC2482, IC2539, IC2540, IC2538, IC2537, IC2532, IC2533, IC2529, IC2530, IC2531, IC2522, IC2520, IC2521, IC2517, IC2518, IC2523, IC2525, IC2466, IC2528, IC2527, IC2464, IC2515, IC2507, IC2513, IC2514, IC2508, IC2509, IC2510, IC2511, IC2504, IC2502, IC2500, IC2489, IC2467, IC2488, IC2462, IC2463, IC2439, IC2458, IC2436, IC2322, IC2167, IC2454, IC2456, IC2445, IC2446, IC2447, IC2438, IC2440, IC2437, IC2430, IC2432, IC2402, IC2427, IC2433, IC2421, IC2423, IC2428, IC2429, IC2425, IC2409, IC2417, IC2418, IC2419, IC2420, IC2424, IC2422, IC2416, IC2415, IC2405, IC2401, IC2403, IC2390, IC2398, IC2407, IC2406, IC2397, IC2395, IC2384, IC2385, IC2374, IC2375, IC2365, IC2366, IC2379, IC2378, IC2364, IC2394, IC2393, IC2371, IC2372, IC2388, IC2391, IC2382, IC2383, IC2381, IC2386, IC2387, IC2373, IC2363, IC2359, IC2361, IC2362, IC2354, IC2355, IC2356, IC2357, IC2358, IC2353, IC2259, IC2351, IC2352, IC2256, IC2350, IC2193, IC2348, IC2347, IC2349, IC2317, IC2279, IC2157, IC2295, IC2297, IC2339, IC2340, IC2341, IC2310, IC2343, IC2345, IC2336, IC2338, IC2323, IC2335, IC2337, IC2333, IC2319, IC2312, IC2313, IC2300, IC2309, IC2308, IC2296, IC2284, IC2289, IC2276, IC2304, IC2305, IC2306, IC2307, IC2293, IC2299, IC1794, IC2298, IC2294, IC2301, IC2290, IC2292, IC2286, IC2288, IC2281, IC2275, IC2263, IC2215, IC2213, IC2280, IC2283, IC2285, IC2291, IC2270, IC2271, IC2274, IC2272, IC2273, IC2264, IC2265, IC2248, IC2262, IC2255, IC2261, IC2254, IC2257, IC2249, IC2252, IC2250, IC2253, IC2037, IC2212, IC2238, IC2246, IC2251, IC2214, IC2196, IC2203, IC2192, IC2177, IC2195, IC2189, IC2198, IC2188, IC2237, IC2230, IC2224, IC2228, IC2229, IC2216, IC2208, IC2209, IC2210, IC2227, IC2197, IC2200, IC2194, IC2190, IC2191, IC2182, IC2163, IC2165, IC2158, IC2159, IC2162, IC2161, IC2152, IC2153, IC2166, IC2149, IC2150, IC2138, IC1970, IC2142, IC2134, IC2136, IC2128, IC2129, IC2116, IC2117, IC1947, IC2140, IC2135, IC2139, IC2122, IC2121, IC2137, IC2141, IC1932, IC2103, IC2131, IC2132, IC2119, IC2104, IC2106, IC2107, IC2110, IC2130, IC2127, IC2108, IC2109, IC2087, IC2088, IC2111, IC2112, IC2113, IC1988, IC1983, IC2091, IC2094, IC2067, IC2056, IC2059, IC2047, IC2092, IC2093, IC2089, IC2090, IC2066, IC2022, IC2064, IC2065, IC2058, IC2057, IC2073, IC2083, IC2084, IC2081, IC2086, IC2069, IC2060, IC2050, IC2055, IC2061, IC2048, IC2052, IC2054, IC2053, IC2042, IC2044, IC2041, IC2046, IC2043, IC2045, IC2030, IC2014, IC1934, IC2004, IC2026, IC2027, IC2013, IC2015, IC2016, IC2017, IC2018, IC1989, IC1993, IC1998, IC1999, IC1997, IC1995, IC2000, IC2003, IC1979, IC1980, IC1915, IC1984, IC1985, IC1986, IC1959, IC1857, IC1968, IC1966, IC1963, IC1957, IC1958, IC1951, IC1954, IC1892, IC1967, IC1969, IC1950, IC1952, IC1953, IC1955, IC1946, IC1964, IC1965, IC1929, IC1895, IC1895, IC1860, IC1854, IC1931, IC1921, IC1923, IC1925, IC1930, IC1942, IC1943, IC1919, IC1920, IC1928, IC1945, IC1940, IC1941, IC1939, IC1938, IC1924, IC1937, IC1944, IC1935, IC1914, IC1916, IC1917, IC1918, IC1897, IC1900, IC1885, IC1888, IC1898, IC1899, IC1889, IC1891, IC1890, IC1893, IC1894, IC1536, IC1778, IC1843, IC1834, IC1837, IC1882, IC1883, IC1878, IC1879, IC1880, IC1884, IC1877, IC1759, IC1797, IC1859, IC1867, IC1862, IC1849, IC1844, IC1835, IC1858, IC1861, IC1850, IC1848, IC1847, IC2146, IC1827, IC1855, IC1838, IC1841, IC1829, IC1833, IC1816, IC1817, IC1776, IC1750, IC1832, IC1831, IC1828, IC1813, IC1820, IC1808, IC1818, IC1819, IC1811, IC1786, IC1805, IC1799, IC1800, IC1806, IC1807, IC1810, IC1803, IC1809, IC1801, IC1770, IC1788, IC1795, IC1773, IC1774, IC1771, IC1772, IC1784, IC1785, IC1781, IC1738, IC1755, IC1758, IC1760, IC1753, IC1754, IC1748, IC1749, IC1737, IC1734, IC1718, IC1751, IC1752, IC1742, IC1744, IC1735, IC1736, IC1739, IC1740, IC1728, IC1732, IC1733, IC1707, IC1712, IC1717, IC1711, IC1694, IC1666, IC1714, IC1709, IC1710, IC1702, IC1703, IC1698, IC1697, IC1692, IC1696, IC1687, IC1686, IC1688, IC1689, IC1690, IC1691, IC1669, IC1673, IC1672, IC1683, IC1681, IC1682, IC1679, IC1680, IC1670, IC1671, IC1675, IC1648, IC1654, IC1655, IC1660, IC1639, IC1668, IC1661, IC1662, IC1656, IC1657, IC1658, IC1659, IC1650, IC1642, IC1637, IC1638, IC1652, IC1651, IC1645, IC1646, IC1644, IC1630, IC1643, IC1641, IC1629, IC1640, IC1628, IC1635, IC1631, IC1632, IC1633, IC1634, IC1627, IC1626, IC1622, IC1623, IC1624, IC1625, IC1621, IC1557, IC1575, IC1599, IC1603, IC1604, IC1605, IC1556, IC1532, IC1507, IC1462, IC1563, IC1564, IC1550, IC1554, IC1540, IC1531, IC1533, IC1461, IC1596, IC1618, IC1606, IC1607, IC1571, IC1610, IC1570, IC1574, IC1561, IC1569, IC1612, IC1613, IC1608, IC1600, IC1617, IC1566, IC1568, IC1558, IC1559, IC1560, IC1609, IC1601, IC1602, IC1513, IC1469, IC1565, IC1552, IC1555, IC1538, IC1506, IC1551, IC1541, IC1529, IC1512, IC1412, IC1526, IC1514, IC1535, IC1530, IC1528, IC1517, IC1518, IC1496, IC1499, IC1503, IC1504, IC1498, IC1424, IC1429, IC1475, IC1473, IC1470, IC1474, IC1466, IC1467, IC1484, IC1485, IC1476, IC1453, IC1454, IC1450, IC1479, IC1483, IC1446, IC1448, IC1471, IC1472, IC1342, IC1460, IC1459, IC1364, IC1458, IC1455, IC1451, IC1452, IC1408, IC1379, IC1449, IC1406, IC1442, IC1443, IC1436, IC1437, IC1434, IC1435, IC1418, IC1422, IC1421, IC1423, IC1419, IC1420, IC1414, IC1417, IC1414, IC1417, IC1333, IC1394, IC1377, IC1403, IC1375, IC1401, IC1376, IC1410, IC1402, IC1404, IC1378, IC1374, IC1372, IC1365, IC1373, IC1360, IC1361, IC1358, IC1362, IC1363, IC1359, IC1313, IC1314, IC1353, IC1354, IC1355, IC1352, IC1336, IC1338, IC1339, IC1331, IC1337, IC1332, IC1335, IC1334, IC1291, IC1329, IC1330, IC1328, IC1310, IC1300, IC1306, IC1312, IC1309, IC1315, IC1316, IC1297, IC1296, IC1235, IC1110, IC1307, IC1311, IC1326, IC1327, IC1323, IC1320, IC1322, IC1325, IC1274, IC1289, IC1290, IC1234, IC1186, IC1144, IC1293, IC1272, IC1258, IC1295, IC1270, IC1246, IC1239, IC1292, IC1294, IC1264, IC1269, IC1251, IC1252, IC1271, IC1273, IC1262, IC1259, IC1263, IC1256, IC1257, IC1254, IC1253, IC1255, IC1244, IC1226, IC1221, IC1225, IC1240, IC1243, IC1227, IC1228, IC1230, IC1220, IC1219, IC1214, IC1233, IC1211, IC1212, IC1178, IC1237, IC1229, IC1236, IC1205, IC1206, IC1218, IC1192, IC1160, IC1100, IC1201, IC1215, IC1200, IC1193, IC1191, IC1209, IC1198, IC1199, IC1197, IC1194, IC1188, IC1153, IC1154, IC1183, IC1184, IC1168, IC1162, IC1159, IC1181, IC1176, IC1177, IC1171, IC1174, IC1175, IC1172, IC1173, IC1147, IC1145, IC1146, IC1141, IC1142, IC1165, IC1166, IC1167, IC1163, IC1164, IC1156, IC1149, IC1157, IC1158, IC1139, IC1151, IC1152, IC1133, IC1134, IC1121, IC1150, IC1123, IC1136, IC1137, IC1138, IC1135, IC1115, IC1120, IC1132, IC1111, IC1106, IC1116, IC1117, IC1119, IC1105, IC1084, IC1085, IC1104, IC1108, IC1093, IC1095, IC1083, IC1094, IC1103, IC1089, IC1088, IC1086, IC1087, IC1081, IC1082, IC1077, IC1078, IC1079, IC1058, IC1076, IC1075, IC1074, IC1072, IC1073, IC1068, IC1069, IC1064, IC1065, IC1066, IC1067, IC1060, IC1061, IC1050, IC1062, IC1047, IC1051, IC1039, IC1041, IC1030, IC1049, IC1042, IC1044, IC1052, IC1028, IC1040, IC1046, IC1043, IC1029, IC1026, IC1027, IC1025, IC1031, IC1032, IC1007, IC1008, IC1006, IC1014, IC1017, IC1015, IC1004. 5. Product Code: 0042-0010-EU. GTIN: 00813502010961. Serial Numbers: IC6118, IC6119, IC5129, IC5042, IC5919, IC5282, IC6263, IC6261, IC5580, IC5592, IC5038, IC7156, IC6779, IC6776, IC6462, IC6418, IC6379, IC6416, IC6417, IC6383, IC6384, IC6377, IC6378, IC6344, IC6305, IC6336, IC6337, IC6304, IC6303, IC6342, IC6343, IC6302, IC6297, IC6298, IC6299, IC6282, IC6283, IC6278, IC6279, IC6277, IC6260, IC6259, IC6257, IC6258, IC6235, IC6256, IC6070, IC6231, IC6232, IC6234, IC6175, IC6226, IC6168, IC6169, IC6166, IC6167, IC6122, IC6123, IC6121, IC6174, IC6019, IC6172, IC6173, IC6014, IC6015, IC6171, IC6075, IC6116, IC6117, IC6120, IC6124, IC6073, IC6074, IC6069, IC6067, IC6068, IC6024, IC6025, IC6022, IC6023, IC6020, IC6021, IC5966, IC5967, IC6016, IC6017, IC5968, IC6012, IC5924, IC5923, IC5900, IC5963, IC5964, IC5918, IC5921, IC5905, IC5916, IC5922, IC5925, IC5903, IC5902, IC5920, IC5897, IC5898, IC5813, IC5814, IC5896, IC5811, IC5812, IC5809, IC5810, IC5808, IC5807, IC5806, IC5804, IC5805, IC5802, IC5803, IC5671, IC5672, IC5668, IC5669, IC5666, IC5667, IC5644, IC5645, IC5641, IC5643, IC5639, IC5640, IC5638, IC5642, IC5595, IC5635, IC5636, IC5533, IC5567, IC5628, IC5631, IC5629, IC5630, IC5632, IC5594, IC5633, IC5634, IC5627, IC5529, IC5585, IC5586, IC5583, IC5584, IC5570, IC5571, IC5569, IC5577, IC5566, IC5526, IC5532, IC5527, IC5528, IC5530, IC5531, IC5415, IC5412, IC5413, IC5410, IC5411, IC5408, IC5383, IC5407, IC5403, IC5404, IC5401, IC5402, IC5396, IC5398, IC5397, IC5378, IC5376, IC5377, IC5355, IC5281, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5283, IC5284, IC5285, IC5233, IC5234, IC5163, IC5164, IC5161, IC5162, IC5082, IC5157, IC5159, IC5160, IC5158, IC5145, IC5156, IC5140, IC5142, IC5143, IC5144, IC5141, IC5138, IC5139, IC5135, IC5136, IC5137, IC5133, IC5134, IC5132, IC4960, IC5127, IC5115, IC5126, IC5114, IC5101, IC5102, IC5103, IC5105, IC5104, IC5098, IC5106, IC5111, IC5100, IC5109, IC5110, IC5107, IC5108, IC5113, IC5112, IC5097, IC5099, IC5085, IC5096, IC5084, IC5080, IC5081, IC5078, IC5079, IC5076, IC5077, IC5044, IC5045, IC5040, IC5041, IC5039, IC4958, IC4959, IC4961, IC4957, IC4955, IC4953, IC4954, IC4952, IC4949, IC4950, IC4947, IC4948, IC4946. 6. Product Code: 0042-0010-US. GTIN: 00813502010985. Serial Numbers: IC7251, IC7037, IC7023, IC7021, IC6996, IC6998, IC6999, IC6975, IC6997, IC6974, IC6972, IC6963, IC6964, IC6959, IC6958, IC6957, IC5971, IC5970. 7. Product Code: 0042-0040-US. GTIN: 00813502011401. Serial Numbers: IC7186.
Where was it sold?
Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abiomed
All 74| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Impella Optical Controller, Automated Impella Controller recalled | Abiomed | Device Malfunction | Nationwide |
| Device | CLASS I | Impella Optical Controller with the below product recalled by Abiomed | Abiomed | Device Malfunction | Nationwide |
| Device | CLASS I | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Device Malfunction | Nationwide |
| Device | CLASS I | Introducer Kit, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
| Device | CLASS I | Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed | Abiomed | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| Device | CLASS II | EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled | embecta Medical II | Other | Nationwide |