{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210304", "product_res_number": "Z-0257-2025", "event_date_initiated": "2024-09-19", "event_date_posted": "2024-10-29", "recall_status": "Open, Classified", "res_event_number": "95447", "product_code": "LIT", "k_numbers": [ "K163231" ], "product_description": "Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)", "code_info": "1. 5mm x 40mm x 75cm (CFN CH05-40-75US):\nUDI-DI: 10884521812260;\nLot Numbers: 22201047, 22201424, 22201425, 22202802, 22203008, 22203009, 22203040, 22300536, 22300970, 22300971, 22301116, 22301270, 22400129, 22400572, 22400573, Added 12/13/2024: 22202643, 22300000, 22300969, 22301117. Expansion 12/05/2024 with additional serial numbers: 22202643, 22300000, 22300969, 22301117.\n\n2. 6mm x 40mm x 75cm (CFN CH06-40-75US):\nUDI-DI: 10884521812277;\nLot Numbers: 22201337, 22201908, 22202412, 22202413, 22202611, 22202612, 22202801, 22300151, 22300318, 22300319, 22300320, 22300862, 22300965, 22301285, 22301494, 22301661, 22301895, 22301896, 22302180, 22400243, 22400244, 22400574, 22400576.\n\n3. 7mm x 40mm x 75cm (CFN CH07-40-75US):\nUDI-DI: 10884521812284;\nLot Numbers: 22200635, 22201897, 22202223, 22202426, 22202427, 22202800, 22203055, 22300321, 22300864, 22301028, 22301648, 22301649, 22301889, 22301890, 22302033, 22302034.\n\n4. 8mm x 40mm x 75cm (CFN CH08-40-75US): \nUDI-DI: 10884521812291;\nLot Numbers: 22201015, 22201046, 22201087, 22201785, 22201786, 22201813, 22202144, 22202145, 22202644, 22202645, 22300165, 22300230, 22300534, 22300535, 22300876, 22300877, 22300966, 22301133, 22301134, 22301299, 22301495, 22302032, 22400154, 22400164, 22400165.\n\n5. 9mm x 40mm x 75cm (CFN CH09-40-75US):\nUDI-DI: 10884521812307;\nLot Numbers: 22201364, 22202428, 22203026, 22300152, 22300539, 22301123, 22301124, 22400698, 22400699, 22400858.\n\n6. 10mm x 40mm x 75cm (CFN CH10-40-75US):\nUDI-DI: 10884521812314;\nLot Numbers: 22201814, 22201871, 22202646, 22300185, 22300219, 22300231, 22300863, 22301300, 22301301, 22302026, 22302031, 22302044, 22400153, 22400247, Added 12/13/2024: 22200739, 22201815, 22202176, 22202177, 22202799. Expansion 12/05/2024 with additional serial numbers: 22200739, 22201815, 22202176, 22202177, 22202799.\n\n7. 12mm x 40mm x 75cm (CFN CH12-40-75US):\nUDI-DI: 10884521812321;\nLot Numbers: 22201391, 22201872, 22202781, 22300301, 22300302, 22300878, 22300967, 22300968, 22301269, 22400128, 22400279, Added 12/13/2024: 22202212, 22202213, 22203025, 22300300. Expansion 12/05/2024 with additional serial numbers: 22202212, 22202213, 22203025, 22300300.", "firm_fei_number": "1282497", "recalling_firm": "Covidien LP", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "reason_for_recall": "Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.", "root_cause_description": "Under Investigation by firm", "action": "An \"URGENT: MEDICAL DEVICE RECALL\" notification letter dated September 2024 was sent to customers.\n\nRequired Actions:\n1. Quarantine and discontinue use of unused affected product lot numbers immediately (see Attachment A).\n2. Return all unused products from your inventory to Medtronic. Please contact: rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA).\na. Credit for the returned affected product will be issued based on the RGA number.\nb. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor.\n3. Complete and return the enclosed Consignee Confirmation Product Retrieval to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. Please copy your local sales representative on this email when possible.\n4. Share this notice with those who need to be aware within your organization or to any organization including, but not limited to, surgeons, interventionalists, or other staff. Please maintain a copy of this notice in your records.\n\nIf you have questions regarding this communication, please contact your local representative or Customer Service at 800-962-9888, option 2 (Monday Friday 8:00 a.m. to 6:30 p.m.).", "product_quantity": "16,336 units", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey.", "openfda": { "k_number": [ "K130911", "K220410", "K192318", "K111899", "K121385", "K130293", "K831659", "K071309", "K901601", "K901767", "K945943", "K924358", "K080264", "K181128", "K951248", "K943298", "K993639", "K092286", "K843501", "K972800", "K880612", "K980390", "K052038", "K102705", "K073472", "K221832", "K822245", "K173621", "K942400", "K970466", "K123358", "K133861", "K941706", "K955886", "K871011", "K921706", "K093636", 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"K110319", "K063563" ], "pma_number": [ "P950020" ], "registration_number": [ "", "3008700817", "9681477", "1282497", "3004730544", "3005580113", "3027395815", "1000393132", "1319639", "3002807315", "1054241", "2528981", "3015002281", "2020394", "3011088743", "9681260", "1000563940", "3021140368", "3019677404", "3005718570", "3014687026", "3014656749", "3006082230", "3010391265", "1721676", "9617601", "3003775186", "3022627847", "1000121056", "1422634", "1055236", "3000247873", "3010432890", "3007738736", "3010220595", "9618000", "1318694", "1643817", "9614654", "3004091615", "3016927279", "3014390222", "1016427", "2939561", "1043214", "3005994106", "2124215", "3011142981", "1219930", "3002806603", "1820334", "3030574705", "3015453963", "2024168", "1220452", "3002807090", "3027343398", "2134265", "3008261722", "2183744", "3006550224", "2183870", "3018805824", "2134626", "2011171", "1721686", "3009018440", "9616666", "3012050423", "3015910259", "3009564766", "3010291427", "3013944123", 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