BD Recanalization System, REF: BDRECANSYSTEM

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 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.

Code information: 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

Distribution pattern: 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