FDA recall, , Moderate risk
Thoratec CentriMag Blood Pump and Kits
The CentriMag blood pump may not fit into the motor and may not lock securely, which could lead to stroke, embolism, or death.
Summary by Recall Canary from the FDA notice
What happened
Thoratec LLC of Pleasanton, California, recalled the CentriMag Blood Pump and related kits because the pump may not fit into the motor and may not be securely locked using the screw-in locking feature. Failure to properly lock the pump into the motor may not cause a pump-not-inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, or death.
The recall began October 10, 2025, and was added to the FDA's Enforcement Report on January 15, 2026. The products were distributed nationwide in the United States and worldwide, including countries such as Canada, Germany, and the United Kingdom. The affected products include the CentriMag Blood Pump, CentriMag RVAD HDE KIT, CentriMag Pre-connected Pack, CentriMag VAD KIT, and Blood Pump with CentriMag Acute Circulatory Support System for ECMO.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Incomplete list: 1,000 of 2,179 UDI-DIs shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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- UDI-DI
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Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Minnesota, Pennsylvania, Oklahoma, Florida, California, Oregon, Illinois, New York, Delaware, Georgia, New Jersey, North Carolina, Wisconsin, Ohio, Arizona, Arkansas, Texas, Tennessee, Missouri, Massachusetts, Montana, Kentucky, Nebraska, West Virginia, Virginia, Maine, North Dakota, Alabama, Colorado, District of Columbia, Mississippi, Indiana, Michigan, Connecticut, South Carolina, Washington, New Mexico, Maryland, Hawaii, Idaho, Iowa, Louisiana, Utah, Rhode Island, Nevada 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.
- Company
- Thoratec LLCPleasanton, California
- Hazard
- Foreign object
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97784
- Recall number
- Z-1099-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary