CLASS I ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Impella Optical Controller with the below product recalled by Abiomed

Abiomed is recalling Impella Optical Controller with the below product descriptions and corresponding, distributed nationwide in the US. The recall was initiated on 12 Aug 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC6788, IC6789, IC6790, IC6791, IC6792, IC6793, IC6794, IC6795, IC6866, IC6867, IC6868, IC6869, IC6870, IC6871, IC6872, IC6873, IC6874, IC6875, IC6936, IC6937, IC6938, IC6939, IC6940, IC6941, IC6942, IC6943, IC6944, IC6945, IC6946, IC6949, IC6950, IC6951, IC6952, IC6954, IC6955, IC6986, IC6987, IC6988, IC7047, IC7048, IC7049, IC7050, IC7051, IC7052, IC7053, IC7054, IC7055, IC7156, IC7157, IC7158, IC7159, IC7160, IC7161, IC7163, IC7164, IC7226, IC7227, IC7232, IC7233, IC7234, IC7235, IC7266, IC7267, IC7268, IC7269, IC7270, IC7271, IC7272, IC7273, IC7274, IC7275, IC7356, IC7357, IC7358, IC7359, IC7360, IC7361, IC7362, IC7363, IC7364, IC7457, IC7458, IC7459, IC7460, IC7461, IC7462, IC7463, IC7464, IC7465, IC7523, IC7524, IC7525, IC7526, IC7528, IC7586, IC7587, IC7588, IC7589, IC7590, IC7620, IC7621, IC7622, IC7623, IC7624, IC7626, IC7627, IC7628, IC7710, IC7711, IC7738, IC7739, IC7792, IC7793, IC7821, IC7822, IC7823, IC7824, IC7826, IC7829, IC7830, IC7860, IC7863, IC7864, IC7865, IC7866, IC7867, IC7868, IC7869, IC7920, IC7939, IC7943, IC7944, IC7947, IC7953, IC7956, IC7958, IC7964, IC7965, IC8011, IC8012, IC8059, IC8060, IC8061, IC8063, IC8067, IC8068, IC8071, IC8073, IC8074, IC8075, IC8117, IC8118, IC8119, IC8122, IC8123, IC8124, IC8125, IC8145, IC8146, IC8159, IC8160, IC8161, IC8165, IC8201, IC8202, IC8203, IC8204, IC8205, IC8206, IC8217, IC8218, IC8219, IC8220, IC8221, IC8226, IC8252, IC8253, IC8254, IC8255, IC8256, IC8257, IC8258, IC8259, IC8260, IC8261, IC8262, IC8336, IC8340, IC8342, IC8344, IC8345, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8421, IC8422, IC8423, IC8424, IC8439, IC8443, IC8444, IC8450, IC8457, IC8482, IC8486, IC8487, IC8499, IC8511, IC8512, IC8584, IC8586, IC8591, IC8592, IC8600, IC8610, IC8622, IC8625, IC8639, IC8643, IC8644, IC8645, IC8647, IC8648, IC8649, IC8661, IC8662, IC8663, IC8664, IC8690, IC8691, IC8693, IC8696, IC8723, IC8725, IC8726, IC8729, IC8737, IC8739, IC8931, IC8338, IC8339, IC8596, IC8608, IC8655, IC8665, IC8692, IC8761, IC8762, IC8813, IC9349, IC9372, IC7827, IC7828, IC8133, IC8134, IC9385, IC8404, IC8420, IC11746, IC12327, IC12344, IC13040, IC8425, IC8426, IC8427, IC8428, IC7861, IC7862, IC7954, IC7957, IC8120, IC8121, IC8222, IC8225, IC9027, IC9090, IC9091, IC8062, IC8066, IC5042, IC5129, IC5282, IC5580, IC5919, IC6118, IC6119, IC6261, IC6263, IC6459, IC7456, IC7529, IC7797, IC7941, IC7942, IC7955, IC8147, IC8442, IC8495, IC8513, IC8590, IC8753, IC8754, IC8755, IC8764, IC8765, IC9085, IC9230, IC9367, IC8875, IC9383, IC9796, IC9866, IC9974, IC10023, IC10024, IC9996, IC9998, IC11491, IC11451, IC11456, IC11497, IC11500, IC11741, IC11742, IC11745, IC11747, IC11748, IC11749; 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN; UDI-DI: 00813502011425; Serial Numbers: IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8609, IC8980, IC9177, IC9178, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970; 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK; UDI-DI: 00813502010978; Serial Numbers: IC8105, IC8106, IC8308, IC8315, IC8316, IC8335, IC8541, IC8542, IC8543, IC8895, IC9163, IC10013, IC10014, IC11023, IC11183, IC11442, IC12507, IC9133, IC9443, IC10012, IC10015, IC10039, IC10044, IC10319, IC10320, IC10640, IC10641, IC10645, IC10646, IC10648, IC10649, IC11019, IC11026, IC11027, IC11028, IC11048, IC11071, IC11086, IC11190, IC11201, IC11202, IC11441, IC11444, IC11445, IC11448, IC12503, IC12504, IC12579, IC12580, IC12581, IC12582, IC12719, IC12720, IC12721, IC12723, IC13159, IC13201, IC13204, IC13219, IC13220, IC13221, IC13278, IC13279, IC13280, IC8334, IC8767, IC8768, IC8774, IC9441, IC9445, IC9599, IC10040, IC10043, IC10808, IC11186, IC11211, IC11440, IC12505, IC12506, IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC8113, IC8114, IC8115, IC8116, IC8127, IC8129, IC8297, IC8331, IC8332, IC8333, IC8561, IC8563, IC8593, IC8594, IC9442, IC9444, IC9447, IC9448, IC9450, IC8295; 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US; UDI-DI: 00813502010985; Serial Numbers: IC11685, IC5970, IC5971, IC6956, IC6957, IC6958, IC6959, IC6960, IC6961, IC6962, IC6963, IC6964, IC6965, IC6966, IC6967, IC6968, IC6969, IC6970, IC6971, IC6972, IC6973, IC6974, IC6975, IC6996, IC6997, IC6998, IC6999, IC7000, IC7001, IC7002, IC7003, IC7004, IC7005, IC7006, IC7007, IC7009, IC7011, IC7012, IC7013, IC7014, IC7015, IC7016, IC7017, IC7018, IC7019, IC7020, IC7021, IC7022, IC7023, IC7024, IC7025, IC7036, IC7037, IC7038, IC7109, IC7110, IC7111, IC7112, IC7113, IC7114, IC7115, IC7116, IC7117, IC7118, IC7119, IC7120, IC7123, IC7125, IC7127, IC7128, IC7129, IC7130, IC7131, IC7132, IC7135, IC7136, IC7137, IC7138, IC7139, IC7150, IC7151, IC7152, IC7153, IC7154, IC7155, IC7166, IC7167, IC7168, IC7169, IC7170, IC7171, IC7172, IC7173, IC7174, IC7175, IC7176, IC7177, IC7178, IC7179, IC7192, IC7193, IC7194, IC7195, IC7196, IC7197, IC7198, IC7199, IC7200, IC7201, IC7202, IC7203, IC7204, IC7205, IC7206, IC7208, IC7209, IC7210, IC7211, IC7212, IC7213, IC7214, IC7215, IC7216, IC7217, IC7222, IC7223, IC7224, IC7225, IC7236, IC7237, IC7238, IC7239, IC7240, IC7241, IC7243, IC7244, IC7245, IC7246, IC7247, IC7249, IC7250, IC7251, IC7252, IC7253, IC7254, IC7255, IC7276, IC7277, IC7278, IC7279, IC7280, IC7281, IC7282, IC7283, IC7284, IC7285, IC7296, IC7297, IC7298, IC7299, IC7300, IC7301, IC7302, IC7303, IC7304, IC7305, IC7306, IC7307, IC7308, IC7313, IC7315, IC7316, IC7317, IC7318, IC7319, IC7320, IC7321, IC7322, IC7324, IC7325, IC7326, IC7327, IC7328, IC7329, IC7330, IC7331, IC7332, IC7333, IC7334, IC7335, IC7336, IC7337, IC7338, IC7344, IC7345, IC7346, IC7347, IC7348, IC7349, IC7350, IC7351, IC7352, IC7353, IC7354, IC7355, IC7366, IC7367, IC7368, IC7369, IC7370, IC7371, IC7372, IC7373, IC7374, IC7375, IC7396, IC7397, IC7398, IC7399, IC7400, IC7401, IC7402, IC7403, IC7404, IC7405, IC7466, IC7467, IC7468, IC7469, IC7470, IC7471, IC7472, IC7473, IC7474, IC7476, IC7477, IC7478, IC7479, IC7480, IC7481, IC7482, IC7483, IC7484, IC7485, IC7486, IC7487, IC7488, IC7489, IC7490, IC7491, IC7492, IC7493, IC7494, IC7495, IC7496, IC7497, IC7498, IC7499, IC7500, IC7501, IC7502, IC7503, IC7504, IC7505, IC7506, IC7507, IC7508, IC7509, IC7510, IC7511, IC7512, IC7513, IC7514, IC7515, IC7516, IC7517, IC7518, IC7534, IC7535, IC7536, IC7537, IC7538, IC7539, IC7540, IC7541, IC7542, IC7543, IC7544, IC7545, IC7547, IC7548, IC7549, IC7550, IC7551, IC7552, IC7553, IC7554, IC7555, IC7556, IC7557, IC7558, IC7559, IC7561, IC7564, IC7570, IC7573, IC7574, IC7599, IC7600, IC7601, IC7602, IC7603, IC7604, IC7605, IC7616, IC7617, IC7618, IC7619, IC7658, IC7659, IC7660, IC7661, IC7662, IC7663, IC7664, IC7665, IC7676, IC7677, IC7678, IC7679, IC7699, IC7700, IC7701, IC7702, IC7703, IC7704, IC7705, IC7706, IC7707, IC7712, IC7713, IC7714, IC7715, IC7726, IC7727, IC7728, IC7729, IC7730, IC7731, IC7732, IC7733, IC7734, IC7735, IC7736, IC7737, IC7742, IC7743, IC7744, IC7745, IC7756, IC7757, IC7758, IC7759, IC7760, IC7761, IC7771, IC7772, IC7773, IC7774, IC7775, IC7786, IC7787, IC7788, IC7789, IC7790, IC7791, IC7802, IC7803, IC7804, IC7805, IC7816, IC7817, IC7818, IC7819, IC7820, IC7877, IC7878, IC7879, IC7880, IC7882, IC7883, IC7884, IC7890, IC7893, IC7894, IC7906, IC7908, IC7974, IC8002, IC8003, IC8004, IC8006, IC8008, IC8026, IC8029, IC8034, IC8035, IC8037, IC8040, IC8041, IC10049, IC10066, IC10587, IC9228, IC9229, IC9610, IC9622, IC9773, IC9780, IC9781, IC9782, IC10102, IC10103, IC10318, IC10463, IC10589, IC10979, IC11299, IC12316, IC12758, IC12859, IC12900, IC13812, IC9989, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC11656, IC11670, IC11674, IC11677, IC12214, IC12279, IC12414, IC12415, IC12417, IC12418, IC12419, IC12820, IC12857, IC12858, IC12870, IC12885, IC12973, IC12974, IC13231, IC13263, IC13264, IC13265, IC13268, IC13270, IC13271, IC13681, IC13682, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC7010, IC12884, IC12953, IC13232, IC13698, IC12968, IC13212, IC13269, IC13862;

Quantity recalled1422 units (487 US, 935 OUS)

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-3149-2026
FDA event ID: 99671
Recalling firm: Abiomed, Danvers, MA
Classification: Class I
Status: Ongoing
Recall initiated: 12 Aug 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

12 Aug 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+35 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.

Where it was distributed

Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Nationwide

Questions about this recall

Why was it recalled?

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Which lots are affected?

1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC6788, IC6789, IC6790, IC6791, IC6792, IC6793, IC6794, IC6795, IC6866, IC6867, IC6868, IC6869, IC6870, IC6871, IC6872, IC6873, IC6874, IC6875, IC6936, IC6937, IC6938, IC6939, IC6940, IC6941, IC6942, IC6943, IC6944, IC6945, IC6946, IC6949, IC6950, IC6951, IC6952, IC6954, IC6955, IC6986, IC6987, IC6988, IC7047, IC7048, IC7049, IC7050, IC7051, IC7052, IC7053, IC7054, IC7055, IC7156, IC7157, IC7158, IC7159, IC7160, IC7161, IC7163, IC7164, IC7226, IC7227, IC7232, IC7233, IC7234, IC7235, IC7266, IC7267, IC7268, IC7269, IC7270, IC7271, IC7272, IC7273, IC7274, IC7275, IC7356, IC7357, IC7358, IC7359, IC7360, IC7361, IC7362, IC7363, IC7364, IC7457, IC7458, IC7459, IC7460, IC7461, IC7462, IC7463, IC7464, IC7465, IC7523, IC7524, IC7525, IC7526, IC7528, IC7586, IC7587, IC7588, IC7589, IC7590, IC7620, IC7621, IC7622, IC7623, IC7624, IC7626, IC7627, IC7628, IC7710, IC7711, IC7738, IC7739, IC7792, IC7793, IC7821, IC7822, IC7823, IC7824, IC7826, IC7829, IC7830, IC7860, IC7863, IC7864, IC7865, IC7866, IC7867, IC7868, IC7869, IC7920, IC7939, IC7943, IC7944, IC7947, IC7953, IC7956, IC7958, IC7964, IC7965, IC8011, IC8012, IC8059, IC8060, IC8061, IC8063, IC8067, IC8068, IC8071, IC8073, IC8074, IC8075, IC8117, IC8118, IC8119, IC8122, IC8123, IC8124, IC8125, IC8145, IC8146, IC8159, IC8160, IC8161, IC8165, IC8201, IC8202, IC8203, IC8204, IC8205, IC8206, IC8217, IC8218, IC8219, IC8220, IC8221, IC8226, IC8252, IC8253, IC8254, IC8255, IC8256, IC8257, IC8258, IC8259, IC8260, IC8261, IC8262, IC8336, IC8340, IC8342, IC8344, IC8345, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8421, IC8422, IC8423, IC8424, IC8439, IC8443, IC8444, IC8450, IC8457, IC8482, IC8486, IC8487, IC8499, IC8511, IC8512, IC8584, IC8586, IC8591, IC8592, IC8600, IC8610, IC8622, IC8625, IC8639, IC8643, IC8644, IC8645, IC8647, IC8648, IC8649, IC8661, IC8662, IC8663, IC8664, IC8690, IC8691, IC8693, IC8696, IC8723, IC8725, IC8726, IC8729, IC8737, IC8739, IC8931, IC8338, IC8339, IC8596, IC8608, IC8655, IC8665, IC8692, IC8761, IC8762, IC8813, IC9349, IC9372, IC7827, IC7828, IC8133, IC8134, IC9385, IC8404, IC8420, IC11746, IC12327, IC12344, IC13040, IC8425, IC8426, IC8427, IC8428, IC7861, IC7862, IC7954, IC7957, IC8120, IC8121, IC8222, IC8225, IC9027, IC9090, IC9091, IC8062, IC8066, IC5042, IC5129, IC5282, IC5580, IC5919, IC6118, IC6119, IC6261, IC6263, IC6459, IC7456, IC7529, IC7797, IC7941, IC7942, IC7955, IC8147, IC8442, IC8495, IC8513, IC8590, IC8753, IC8754, IC8755, IC8764, IC8765, IC9085, IC9230, IC9367, IC8875, IC9383, IC9796, IC9866, IC9974, IC10023, IC10024, IC9996, IC9998, IC11491, IC11451, IC11456, IC11497, IC11500, IC11741, IC11742, IC11745, IC11747, IC11748, IC11749; 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN; UDI-DI: 00813502011425; Serial Numbers: IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8609, IC8980, IC9177, IC9178, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970; 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK; UDI-DI: 00813502010978; Serial Numbers: IC8105, IC8106, IC8308, IC8315, IC8316, IC8335, IC8541, IC8542, IC8543, IC8895, IC9163, IC10013, IC10014, IC11023, IC11183, IC11442, IC12507, IC9133, IC9443, IC10012, IC10015, IC10039, IC10044, IC10319, IC10320, IC10640, IC10641, IC10645, IC10646, IC10648, IC10649, IC11019, IC11026, IC11027, IC11028, IC11048, IC11071, IC11086, IC11190, IC11201, IC11202, IC11441, IC11444, IC11445, IC11448, IC12503, IC12504, IC12579, IC12580, IC12581, IC12582, IC12719, IC12720, IC12721, IC12723, IC13159, IC13201, IC13204, IC13219, IC13220, IC13221, IC13278, IC13279, IC13280, IC8334, IC8767, IC8768, IC8774, IC9441, IC9445, IC9599, IC10040, IC10043, IC10808, IC11186, IC11211, IC11440, IC12505, IC12506, IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC8113, IC8114, IC8115, IC8116, IC8127, IC8129, IC8297, IC8331, IC8332, IC8333, IC8561, IC8563, IC8593, IC8594, IC9442, IC9444, IC9447, IC9448, IC9450, IC8295; 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US; UDI-DI: 00813502010985; Serial Numbers: IC11685, IC5970, IC5971, IC6956, IC6957, IC6958, IC6959, IC6960, IC6961, IC6962, IC6963, IC6964, IC6965, IC6966, IC6967, IC6968, IC6969, IC6970, IC6971, IC6972, IC6973, IC6974, IC6975, IC6996, IC6997, IC6998, IC6999, IC7000, IC7001, IC7002, IC7003, IC7004, IC7005, IC7006, IC7007, IC7009, IC7011, IC7012, IC7013, IC7014, IC7015, IC7016, IC7017, IC7018, IC7019, IC7020, IC7021, IC7022, IC7023, IC7024, IC7025, IC7036, IC7037, IC7038, IC7109, IC7110, IC7111, IC7112, IC7113, IC7114, IC7115, IC7116, IC7117, IC7118, IC7119, IC7120, IC7123, IC7125, IC7127, IC7128, IC7129, IC7130, IC7131, IC7132, IC7135, IC7136, IC7137, IC7138, IC7139, IC7150, IC7151, IC7152, IC7153, IC7154, IC7155, IC7166, IC7167, IC7168, IC7169, IC7170, IC7171, IC7172, IC7173, IC7174, IC7175, IC7176, IC7177, IC7178, IC7179, IC7192, IC7193, IC7194, IC7195, IC7196, IC7197, IC7198, IC7199, IC7200, IC7201, IC7202, IC7203, IC7204, IC7205, IC7206, IC7208, IC7209, IC7210, IC7211, IC7212, IC7213, IC7214, IC7215, IC7216, IC7217, IC7222, IC7223, IC7224, IC7225, IC7236, IC7237, IC7238, IC7239, IC7240, IC7241, IC7243, IC7244, IC7245, IC7246, IC7247, IC7249, IC7250, IC7251, IC7252, IC7253, IC7254, IC7255, IC7276, IC7277, IC7278, IC7279, IC7280, IC7281, IC7282, IC7283, IC7284, IC7285, IC7296, IC7297, IC7298, IC7299, IC7300, IC7301, IC7302, IC7303, IC7304, IC7305, IC7306, IC7307, IC7308, IC7313, IC7315, IC7316, IC7317, IC7318, IC7319, IC7320, IC7321, IC7322, IC7324, IC7325, IC7326, IC7327, IC7328, IC7329, IC7330, IC7331, IC7332, IC7333, IC7334, IC7335, IC7336, IC7337, IC7338, IC7344, IC7345, IC7346, IC7347, IC7348, IC7349, IC7350, IC7351, IC7352, IC7353, IC7354, IC7355, IC7366, IC7367, IC7368, IC7369, IC7370, IC7371, IC7372, IC7373, IC7374, IC7375, IC7396, IC7397, IC7398, IC7399, IC7400, IC7401, IC7402, IC7403, IC7404, IC7405, IC7466, IC7467, IC7468, IC7469, IC7470, IC7471, IC7472, IC7473, IC7474, IC7476, IC7477, IC7478, IC7479, IC7480, IC7481, IC7482, IC7483, IC7484, IC7485, IC7486, IC7487, IC7488, IC7489, IC7490, IC7491, IC7492, IC7493, IC7494, IC7495, IC7496, IC7497, IC7498, IC7499, IC7500, IC7501, IC7502, IC7503, IC7504, IC7505, IC7506, IC7507, IC7508, IC7509, IC7510, IC7511, IC7512, IC7513, IC7514, IC7515, IC7516, IC7517, IC7518, IC7534, IC7535, IC7536, IC7537, IC7538, IC7539, IC7540, IC7541, IC7542, IC7543, IC7544, IC7545, IC7547, IC7548, IC7549, IC7550, IC7551, IC7552, IC7553, IC7554, IC7555, IC7556, IC7557, IC7558, IC7559, IC7561, IC7564, IC7570, IC7573, IC7574, IC7599, IC7600, IC7601, IC7602, IC7603, IC7604, IC7605, IC7616, IC7617, IC7618, IC7619, IC7658, IC7659, IC7660, IC7661, IC7662, IC7663, IC7664, IC7665, IC7676, IC7677, IC7678, IC7679, IC7699, IC7700, IC7701, IC7702, IC7703, IC7704, IC7705, IC7706, IC7707, IC7712, IC7713, IC7714, IC7715, IC7726, IC7727, IC7728, IC7729, IC7730, IC7731, IC7732, IC7733, IC7734, IC7735, IC7736, IC7737, IC7742, IC7743, IC7744, IC7745, IC7756, IC7757, IC7758, IC7759, IC7760, IC7761, IC7771, IC7772, IC7773, IC7774, IC7775, IC7786, IC7787, IC7788, IC7789, IC7790, IC7791, IC7802, IC7803, IC7804, IC7805, IC7816, IC7817, IC7818, IC7819, IC7820, IC7877, IC7878, IC7879, IC7880, IC7882, IC7883, IC7884, IC7890, IC7893, IC7894, IC7906, IC7908, IC7974, IC8002, IC8003, IC8004, IC8006, IC8008, IC8026, IC8029, IC8034, IC8035, IC8037, IC8040, IC8041, IC10049, IC10066, IC10587, IC9228, IC9229, IC9610, IC9622, IC9773, IC9780, IC9781, IC9782, IC10102, IC10103, IC10318, IC10463, IC10589, IC10979, IC11299, IC12316, IC12758, IC12859, IC12900, IC13812, IC9989, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC11656, IC11670, IC11674, IC11677, IC12214, IC12279, IC12414, IC12415, IC12417, IC12418, IC12419, IC12820, IC12857, IC12858, IC12870, IC12885, IC12973, IC12974, IC13231, IC13263, IC13264, IC13265, IC13268, IC13270, IC13271, IC13681, IC13682, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC7010, IC12884, IC12953, IC13232, IC13698, IC12968, IC13212, IC13269, IC13862;

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99671

This product is part of a recall event; the main page for the event is Automated Impella Controller (AIC) recalled by Abiomed.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
23 Sep 2026	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide

More recalls from Abiomed

All 73

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Intro Kitand, PKGD, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide

Other Heart & Vascular Devices recalls

All 6,208

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS II	EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide
23 Sep 2026Device	CLASS II	EWO_02512 (Catalog number 320550) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide
23 Sep 2026Device	CLASS I	Power-Trialysis Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide