Summary
The FDA issued a Class II for BD Recanalization System, REF: BDRECANSYSTEM by Bard Peripheral Vascular Inc. Reason: Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute wa.
Details
Source
Device Recall
External ID
Z-0676-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
BD Recanalization System, REF: BDRECANSYSTEM
Lot/Code Info: 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
Quantity Affected: 403
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.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-14
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bard Peripheral Vascular Inc have FDA actions?
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0676-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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