{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204958", "product_res_number": "Z-0676-2024", "event_date_initiated": "2023-11-14", "event_date_posted": "2024-01-05", "recall_status": "Open, Classified", "res_event_number": "93607", "product_code": "PDU", "k_numbers": [ "K203363" ], "product_description": "BD Recanalization System, REF: BDRECANSYSTEM", "code_info": "UDI-DI: 00801741202421. \nSerial Numbers:\nBSX000001,\nBSX000002,\nBSX000003,\nBSX000004,\nBSX000005,\nBSX000006,\nBSX000007,\nBSX000008,\nBSX000009,\nBSX000010,\nBSX000011,\nBSX000012,\nBSX000013,\nBSX000014,\nBSX000015,\nBSX000016,\nBSX000017,\nBSX000018,\nBSX000019,\nBSX000020,\nBSX000021,\nBSX000022,\nBSX000023,\nBSX000024,\nBSX000025,\nBSX000026,\nBSX000027,\nBSX000028,\nBSX000029,\nBSX000030,\nBSX000031,\nBSX000032,\nBSX000033,\nBSX000034,\nBSX000035,\nBSX000036,\nBSX000037,\nBSX000038,\nBSX000039,\nBSX000040,\nBSX000041,\nBSX000042,\nBSX000043,\nBSX000044,\nBSX000045,\nBSX000046,\nBSX000047,\nBSX000048,\nBSX000049,\nBSX000050,\nBSX000051,\nBSX000052,\nBSX000053,\nBSX000054,\nBSX000055,\nBSX000056,\nBSX000057,\nBSX000058,\nBSX000059,\nBSX000060,\nBSX000061,\nBSX000062,\nBSX000063,\nBSX000064,\nBSX000065,\nBSX000066,\nBSX000067,\nBSX000068,\nBSX000109,\nBSX000110,\nBSX000111,\nBSX000112,\nBSX000113,\nBSX000114,\nBSX000115,\nBSX000116,\nBSX000117,\nBSX000118,\nBSX000119,\nBSX000120,\nBSX000121,\nBSX000122,\nBSX000123,\nBSX000124,\nBSX000125,\nBSX000126,\nBSX000127,\nBSX000128,\nBSX000129,\nBSX000130,\nBSX000131,\nBSX000132,\nBSX000133,\nBSX000134,\nBSX000135,\nBSX000136,\nBSX000137,\nBSX000138,\nBSX000139,\nBSX000140,\nBSX000141,\nBSX000142,\nBSX000143,\nBSX000144,\nBSX000145,\nBSX000146,\nBSX000147,\nBSX000148,\nBSX000149,\nBSX000150,\nBSX000151,\nBSX000152,\nBSX000153,\nBSX000154,\nBSX000155,\nBSX000156,\nBSX000157,\nBSX000158,\nBSX000159,\nBSX000160,\nBSX000161,\nBSX000162,\nBSX000163,\nBSX000164,\nBSX000165,\nBSX000166,\nBSX000167,\nBSX000168,\nBSX000169,\nBSX000170,\nBSX000171,\nBSX000172,\nBSX000173,\nBSX000174,\nBSX000175,\nBSX000176,\nBSX000177,\nBSX000178,\nBSX000179,\nBSX000180,\nBSX000181,\nBSX000182,\nBSX000183,\nBSX000184,\nBSX000185,\nBSX000186,\nBSX000187,\nBSX000188,\nBSX000189,\nBSX000190,\nBSX000191,\nBSX000192,\nBSX000193,\nBSX000194,\nBSX000195,\nBSX000196,\nBSX000197,\nBSX000198,\nBSX000199,\nBSX000200,\nBSX000201,\nBSX000202,\nBSX000203,\nBSX000204,\nBSX000205,\nBSX000206,\nBSX000207,\nBSX000208,\nBSX000209,\nBSX000210,\nBSX000211,\nBSX000212,\nBSX000213,\nBSX000214,\nBSX000215,\nBSX000216,\nBSX000217,\nBSX000218,\nBSX000219,\nBSX000220,\nBSX000221,\nBSX000222,\nBSX000223,\nBSX000224,\nBSX000225,\nBSX000226,\nBSX000227,\nBSX000228,\nBSX000229,\nBSX000230,\nBSX000231,\nBSX000232,\nBSX000233,\nBSX000234,\nBSX000235,\nBSX000236,\nBSX000237,\nBSX000238,\nBSX000239,\nBSX000240,\nBSX000241,\nBSX000242,\nBSX000243,\nBSX000244,\nBSX000245,\nBSX000246,\nBSX000247,\nBSX000248,\nBSX000249,\nBSX000250,\nBSX000251,\nBSX000252,\nBSX000253,\nBSX000254,\nBSX000255,\nBSX000256,\nBSX000257,\nBSX000258,\nBSX000259,\nBSX000260,\nBSX000261,\nBSX000262,\nBSX000263,\nBSX000264,\nBSX000265,\nBSX000266,\nBSX000267,\nBSX000268,\nBSX000269,\nBSX000270,\nBSX000271,\nBSX000272,\nBSX000273,\nBSX000274,\nBSX000275,\nBSX000276,\nBSX000277,\nBSX000278,\nBSX000279,\nBSX000280,\nBSX000281,\nBSX000282,\nBSX000283,\nBSX000284,\nBSX000285,\nBSX000286,\nBSX000287,\nBSX000288,\nBSX000289,\nBSX000290,\nBSX000291,\nBSX000292,\nBSX000293,\nBSX000294,\nBSX000295,\nBSX000296,\nBSX000297,\nBSX000298,\nBSX000299,\nBSX000300,\nBSX000301,\nBSX000302,\nBSX000303,\nBSX000304,\nBSX000305,\nBSX000306,\nBSX000307,\nBSX000308,\nBSX000309,\nBSX000310,\nBSX000311,\nBSX000312,\nBSX000313,\nBSX000314,\nBSX000315,\nBSX000316,\nBSX000317,\nBSX000318,\nBSX000319,\nBSX000320,\nBSX000321,\nBSX000322,\nBSX000323,\nBSX000324,\nBSX000325,\nBSX000326,\nBSX000327,\nBSX000328,\nBSX000330,\nBSX000331,\nBSX000332,\nBSX000333,\nBSX000334,\nBSX000335,\nBSX000336,\nBSX000337,\nBSX000338,\nBSX000339,\nBSX000340,\nBSX000341,\nBSX000342,\nBSX000343,\nBSX000344,\nBSX000345,\nBSX000346,\nBSX000347,\nBSX000348,\nBSX000349,\nBSX000350,\nBSX000351,\nBSX000352,\nBSX000353,\nBSX000354,\nBSX000355,\nBSX000356,\nBSX000357,\nBSX000358,\nBSX000359,\nBSX000360,\nBSX000361,\nBSX000362,\nBSX000363,\nBSX000364,\nBSX000365,\nBSX000366,\nBSX000367,\nBSX000368,\nBSX000369,\nBSX000370,\nBSX000371,\nBSX000372,\nBSX000373,\nBSX000374,\nBSX000375,\nBSX000376,\nBSX000377,\nBSX000378,\nBSX000379,\nBSX000380,\nBSX000381,\nBSX000382,\nBSX000383,\nBSX000384,\nBSX000385,\nBSX000386,\nBSX000387,\nBSX000388,\nBSX000389,\nBSX000390,\nBSX000391,\nBSX000392,\nBSX000393,\nBSX000394,\nBSX000395,\nBSX000396,\nBSX000397,\nBSX000398,\nBSX000399,\nBSX000400,\nBSX000401,\nBSX000402,\nBSX000403,\nBSX000404,\nBSX000405,\nBSX000406,\nBSX000407,\nBSX000408,\nBSX000409,\nBSX000410,\nBSX000411,\nBSX000412,\nBSX000413,\nBSX000414,\nBSX000415,\nBSX000416,\nBSX000417,\nBSX000418,\nBSX000419,\nBSX000420,\nBSX000421,\nBSX000422,\nBSX000423,\nBSX000424,\nBSX000425,\nBSX000426,\nBSX000427,\nBSX000428,\nBSX000429,\nBSX000430,\nBSX000431,\nBSX000432,\nBSX000433,\nBSX000434,\nBSX000435,\nBSX000436,\nBSX000437,\nBSX000438,\nBSX000439,\nBSX000440,\nBSX000441,\nBSX000442,\nBSX000443,\nBSX000444", "firm_fei_number": "2020394", "recalling_firm": "Bard Peripheral Vascular Inc", "address_1": "1625 W 3rd St Bldg 1 1625 W 3rd St", "address_2": "Bldg 1", "city": "Tempe", "state": "AZ", "postal_code": "85281-2438", "additional_info_contact": "480-303-2602", "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.", "root_cause_description": "Process design", "action": "On 11/14/23 recall notices were mailed and emailed to customers who were asked to do the following:\n\n1) Discontinue use of affected product and immediately quarantine until ready to return for service activities.\n2) Share this notification with all device users within your facility and network to ensure they are aware of this field action. This notification should also be shared with any organization where the potentially affected devices have been transferred.\n3) Complete and return the response form via email to BDRC49@bd.com\n4) Recalling firm will contact customers to coordinate product return for service.\n\nCustomers with questions can call the firm's North American Regional Complaint Center at 1-844-823-5433, Say \"Recall\" when prompted M-F 8am - 5pm CT, or email productcomplaints@bd.com", "product_quantity": "403", "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", "openfda": { "k_number": [ "K210839", "K221163", "K091119", "K170349", "K072155", "K023114", "K230159", "K221541", "K140438", "K092175", "K071226", "K033535", "K083814", "K210664", "K122380", "K051670", "K211802", "K192211", "K150187", "K050916", "K252315", "K230594", "K081804", "K162418", "K031842", "K101615", "K113838", "K203363", "K232562", "K101777", "K031005", "K131914", "K123532", "K150836", "K220544", "K040067", "K052296", "K052514", "K082143", "K071227", "K183357", "K120533", "K060012", "K101599", "K212468", "K072776", "K123462", "K140185", "K043465", "K251158", "K140288", "K111338", "K251376", "K112308", "K120273", "K201330", "K161208" ], "registration_number": [ "2939520", "1016427", "3009128730", "3009018440", "3030446844", "3013757884", "3023527320", "3009039068", "1450662", "9616099", "1820334", "3000126629", "1221485", "2030598", "1724474", "3008363989", "1313046", "3009882464", "1722746", "3027058844", "1721676", "2528981", "3006082230", "2183744", "3010273872", "3007284006", "3020968442", "2020394", "2126666", "3008789872", "3002807314", "1319639", "3009561706", "3008729892", "1018233", "3003637635", "3008998256", "2011171", "2183870", "1643817", "3005580113" ], "fei_number": [ "2939520", "3003094851", "1016427", "3009128730", "1000518731", "3009018440", "3030446844", "3013757884", "3023527320", "3009039068", "1450662", "1820334", "1000138054", "3000126629", "1221485", "3008363989", "3003528016", "1313046", "3009882464", "1000306216", "3027058844", "1721676", "2528981", "3006082230", "2183744", "3010273872", "3007284006", "3020968442", "2020394", "2126666", "3008789872", "3002807314", "3009561706", "1018233", "3002807555", "3003637635", "3008998256", "2011171", "2183870", "1643817", "3005580113" ], "device_name": "Catheter For Crossing Total Occlusions", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }