Thoratec CentriMag Motor Recalled Due to Electromagnetic Interference Issues
Thoratec is recalling CentriMag Acute Circulatory Support System motors due to reports of motor and pump issues caused by electromagnetic interference.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, and the rubric mandates a score of at least 4 for FDA Class I recalls.
Plain-English summary
Thoratec Switzerland GMBH is recalling the CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002. This component is part of the CentriMag Extracorporeal Blood Pumping System. The recall involves 664 units, with 381 distributed in the U.S. and 283 distributed outside the U.S.
The recall was initiated after reports were received that the CentriMag Systems experienced motor and pump issues resulting from electromagnetic interference (EMI). The affected motor serial numbers range from L05333-0001 to L06608-0024. The U.S. Model 102956 has the UDI 07640135140078.
Distribution was nationwide in the U.S., including government distribution but no military distribution. Foreign distribution included Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom. Users should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
- Manufacturer
- Thoratec Switzerland GMBH
Distribution
Distributed nationwide across the United States.
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