Recall Z-1099-2026— Thoratec LLC

Name: FDA recall Z-1099-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-10

Class II · Ongoing

Class II FDA medical device recall by Thoratec LLC, initiated 2025-10-10. It names one FDA 510(k) clearance: K222038. Product: 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. 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..

Recalling firm: Thoratec LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-10-10
Firm location: Pleasanton, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation)·cleared 2022-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.