Recall Z-1099-2026 · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Thoratec LLC
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
| Date | Jan 15, 2026 (initiated Oct 10, 2025) |
| Status | Open, Classified |
| Reason | 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 | Process design |
| Action | In December 2024 Abbott sent a Product Information Letter to reinforce existing IFU. On 10/10/2025, correction notices were delivered by sales representatives to customers who were asked to do the following: Ensure 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. Continue to follow the IFU, which can be accessed on |
| Quantity | 8399 |
| Distribution | 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, Bahra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System Abbott (Formerly Thoratec Corporation), Dec 8, 2022 |