{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216566", "product_res_number": "Z-1099-2026", "event_date_initiated": "2025-10-10", "event_date_posted": "2026-01-15", "recall_status": "Open, Classified", "res_event_number": "97784", "product_code": "QNR", "k_numbers": [ "K222038" ], "product_description": "CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016;\nCentriMag RVAD HDE KIT, REF: 104318;\nCentriMag Pre-connected Pack, REF: CMAEK00;\nCentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T;\nBlood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. \n\nCentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System", "code_info": "UDI-DI: 07640135140627, 07640135140603, 05415067036414\nIFU: Part(Name) Revision:\nFor US:\n1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C\n2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C\n3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B\n4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D\nFOR OUS:\nARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C\nARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C\nARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A\nARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A\n\nREF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers.\n\nREF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 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20422740), 10715951(20422725, 20422726, 20422728, 20422733, 20422734, 20422735, 20422736, 20422739, 20422740), 10715952(20422742, 20422743, 20422745, 20422746, 20422747, 20422748, 20422754, 20422755, 20422756, 20422757, 20422758), 10715956(20422814, 20422816, 20422818, 20422819, 20422821, 20422822, 20422823, 20422824, 20422825, 20422826), 10715957(20443495, 20443496, 20443497, 20443498, 20443499, 20443500, 20443501, 20443502, 20443503, 20443504, 20443505, 20443506, 20443507, 20443508, 20443512), 10715958(20443513, 20443514, 20443516, 20443517, 20443518, 20443522, 20443524, 20443525, 20443527, 20443528, 20443530), 10757855(20443533, 20443535, 20443536, 20443537, 20443538, 20443539, 20443540, 20443545, 20443546, 20443547, 20443548), 10757856(20443549, 20443551, 20443552, 20443553, 20443555, 20443556, 20443557, 20443558, 20443560, 20443562, 20443563, 20443564, 20443565, 20443566), 10757858(20446755, 20446761), 10757859(20446726, 20446727, 20446728, 20446729, 20446730, 20446731, 20446732, 20446733, 20446734, 20446735, 20446736, 20446737, 20446738, 20446739, 20446740, 20446741, 20446742, 20446743), 10794274(20457826, 20457827, 20457828, 20457829, 20457830, 20457831, 20457835), 10805518(20481842, 20481846, 20481849, 20481850, 20481851, 20481852, 20481853, 20481854, 20481856, 20481857), 10805519(20481869, 20481871, 20481874, 20481876), 10844705(20513099, 20513100, 20513102, 20513104, 20513105, 20513107, 20513110, 20513111, 20513115), 10844706(20513118, 20513122, 20513123, 20513124, 20513131, 20513133), 10944546(20570873, 20570874, 20570881, 20570882, 20570883, 20570884, 20570885, 20570886, 20570887, 20570888)", "firm_fei_number": "2916596", "recalling_firm": "Thoratec LLC", "address_1": "6035 Stoneridge Dr", "city": "Pleasanton", "state": "CA", "postal_code": "94588-3270", "additional_info_contact": "Shelley Lange\n651-756-4091", "reason_for_recall": "Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.", "root_cause_description": "Process design", "action": "In December 2024 Abbott sent a Product Information Letter to reinforce existing IFU.\n\nOn 10/10/2025, correction notices were delivered by sales representatives to customers who were asked to do the following:\n\nEnsure the blood pump is securely locked into the motor, following the IFU. If you are unable to fully rotate and lock a blood pump into a motor, exchange the pump for a new one, and return the original pump to Abbott for a full refund or credit, please contact your Abbott Representative or Abbott Customer Service at 1-800-456-1477. \n\nContinue to follow the IFU, which can be accessed on firm website: https://manuals.eifu.abbott/en/index.html, and also follow the Pump Setup, Appendix A, in this notice, which states:\n\nThe following pictures on Figure 1 clarify the IFU. After matching the grooves on the periphery of the Pump with the fittings on the motor receptacle, proceed with the following: \n\n1. Ensuring that the pump remains flat/level with the motor/ to the pump, Rotate the pump counterclockwise until the matching groove on the pump is located in front of the locking screw. \n2. Turn the locking screw until it is completely seated into the groove and the blood pump is secured in place. \n3. Do not lock screw if groove is not located in front of the locking screw. \n4. Always rely on visual confirmation that the pump is correctly locked in the motor, even if the \"pump not inserted\" alarm is not present. \n\nCommunicate this information with those in your facility to whom it is relevant. \nFirm asks customers to notify all involved parties that support patients with affected devices.\nComplete and return the Acknowledgment and Receipt Form via email to CentriMagNotices@abbott.com\n\nFirm has implemented an in-process manufacturing step to confirm the pumps can be fitted into the motor while continuing with the implementation of corrective actions to help ensure that new blood pumps will lock into the motor.", "product_quantity": "8399", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahrain, CANADA, Cayman Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Italy, Jordan, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Oman, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K230364", "K222038", "K202751", "K250199", "K211830", "K234118", "K233736", "K223898" ], "registration_number": [ "2916596", "9617601", "3003306248", "3011468686", "2133810", "9611665", "1218444", "3010163695", "3004593495" ], "fei_number": [ "3002807095", "2916596", "3000203066", "3003306248", "3011468686", "3002534070", "1218444", "3010163695", "3004593495" ], "device_name": "Blood Pump For Ecmo, Long-Term (> 6 Hours) Use", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4100", "device_class": "2" } } ] }