CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
BD Recanalization System recalled by Bard Peripheral Vascular
Bard Peripheral Vascular is recalling BD Recanalization System, distributed in 34 states. The recall was initiated on 14 Nov 2023 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-0676-2024
- FDA event ID
- 93607
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Nov 2023
- FDA classified
- 5 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 14 Nov 2023 | Recall initiated by company | |
| 5 Jan 2024 | Classified by FDA | +52 days |
| 17 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
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
BD Recanalization System, REF: BDRECANSYSTEM
Where it was distributed
US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN
AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMinnesota
Questions about this recall
Why was it recalled?
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Which lots are affected?
UDI-DI: 00801741202421. Serial Numbers: BSX000001, BSX000002, BSX000003, BSX000004, BSX000005, BSX000006, BSX000007, BSX000008, BSX000009, BSX000010, BSX000011, BSX000012, BSX000013, BSX000014, BSX000015, BSX000016, BSX000017, BSX000018, BSX000019, BSX000020, BSX000021, BSX000022, BSX000023, BSX000024, BSX000025, BSX000026, BSX000027, BSX000028, BSX000029, BSX000030, BSX000031, BSX000032, BSX000033, BSX000034, BSX000035, BSX000036, BSX000037, BSX000038, BSX000039, BSX000040, BSX000041, BSX000042, BSX000043, BSX000044, BSX000045, BSX000046, BSX000047, BSX000048, BSX000049, BSX000050, BSX000051, BSX000052, BSX000053, BSX000054, BSX000055, BSX000056, BSX000057, BSX000058, BSX000059, BSX000060, BSX000061, BSX000062, BSX000063, BSX000064, BSX000065, BSX000066, BSX000067, BSX000068, BSX000109, BSX000110, BSX000111, BSX000112, BSX000113, BSX000114, BSX000115, BSX000116, BSX000117, BSX000118, BSX000119, BSX000120, BSX000121, BSX000122, BSX000123, BSX000124, BSX000125, BSX000126, BSX000127, BSX000128, BSX000129, BSX000130, BSX000131, BSX000132, BSX000133, BSX000134, BSX000135, BSX000136, BSX000137, BSX000138, BSX000139, BSX000140, BSX000141, BSX000142, BSX000143, BSX000144, BSX000145, BSX000146, BSX000147, BSX000148, BSX000149, BSX000150, BSX000151, BSX000152, BSX000153, BSX000154, BSX000155, BSX000156, BSX000157, BSX000158, BSX000159, BSX000160, BSX000161, BSX000162, BSX000163, BSX000164, BSX000165, BSX000166, BSX000167, BSX000168, BSX000169, BSX000170, BSX000171, BSX000172, BSX000173, BSX000174, BSX000175, BSX000176, BSX000177, BSX000178, BSX000179, BSX000180, BSX000181, BSX000182, BSX000183, BSX000184, BSX000185, BSX000186, BSX000187, BSX000188, BSX000189, BSX000190, BSX000191, BSX000192, BSX000193, BSX000194, BSX000195, BSX000196, BSX000197, BSX000198, BSX000199, BSX000200, BSX000201, BSX000202, BSX000203, BSX000204, BSX000205, BSX000206, BSX000207, BSX000208, BSX000209, BSX000210, BSX000211, BSX000212, BSX000213, BSX000214, BSX000215, BSX000216, BSX000217, BSX000218, BSX000219, BSX000220, BSX000221, BSX000222, BSX000223, BSX000224, BSX000225, BSX000226, BSX000227, BSX000228, BSX000229, BSX000230, BSX000231, BSX000232, BSX000233, BSX000234, BSX000235, BSX000236, BSX000237, BSX000238, BSX000239, BSX000240, BSX000241, BSX000242, BSX000243, BSX000244, BSX000245, BSX000246, BSX000247, BSX000248, BSX000249, BSX000250, BSX000251, BSX000252, BSX000253, BSX000254, BSX000255, BSX000256, BSX000257, BSX000258, BSX000259, BSX000260, BSX000261, BSX000262, BSX000263, BSX000264, BSX000265, BSX000266, BSX000267, BSX000268, BSX000269, BSX000270, BSX000271, BSX000272, BSX000273, BSX000274, BSX000275, BSX000276, BSX000277, BSX000278, BSX000279, BSX000280, BSX000281, BSX000282, BSX000283, BSX000284, BSX000285, BSX000286, BSX000287, BSX000288, BSX000289, BSX000290, BSX000291, BSX000292, BSX000293, BSX000294, BSX000295, BSX000296, BSX000297, BSX000298, BSX000299, BSX000300, BSX000301, BSX000302, BSX000303, BSX000304, BSX000305, BSX000306, BSX000307, BSX000308, BSX000309, BSX000310, BSX000311, BSX000312, BSX000313, BSX000314, BSX000315, BSX000316, BSX000317, BSX000318, BSX000319, BSX000320, BSX000321, BSX000322, BSX000323, BSX000324, BSX000325, BSX000326, BSX000327, BSX000328, BSX000330, BSX000331, BSX000332, BSX000333, BSX000334, BSX000335, BSX000336, BSX000337, BSX000338, BSX000339, BSX000340, BSX000341, BSX000342, BSX000343, BSX000344, BSX000345, BSX000346, BSX000347, BSX000348, BSX000349, BSX000350, BSX000351, BSX000352, BSX000353, BSX000354, BSX000355, BSX000356, BSX000357, BSX000358, BSX000359, BSX000360, BSX000361, BSX000362, BSX000363, BSX000364, BSX000365, BSX000366, BSX000367, BSX000368, BSX000369, BSX000370, BSX000371, BSX000372, BSX000373, BSX000374, BSX000375, BSX000376, BSX000377, BSX000378, BSX000379, BSX000380, BSX000381, BSX000382, BSX000383, BSX000384, BSX000385, BSX000386, BSX000387, BSX000388, BSX000389, BSX000390, BSX000391, BSX000392, BSX000393, BSX000394, BSX000395, BSX000396, BSX000397, BSX000398, BSX000399, BSX000400, BSX000401, BSX000402, BSX000403, BSX000404, BSX000405, BSX000406, BSX000407, BSX000408, BSX000409, BSX000410, BSX000411, BSX000412, BSX000413, BSX000414, BSX000415, BSX000416, BSX000417, BSX000418, BSX000419, BSX000420, BSX000421, BSX000422, BSX000423, BSX000424, BSX000425, BSX000426, BSX000427, BSX000428, BSX000429, BSX000430, BSX000431, BSX000432, BSX000433, BSX000434, BSX000435, BSX000436, BSX000437, BSX000438, BSX000439, BSX000440, BSX000441, BSX000442, BSX000443, BSX000444
Where was it sold?
US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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