Thoratec recalled 8,399 CentriMag Blood Pumps on October 10, 2025, due to a significant malfunction risk. The blood pump may not securely lock into the motor, potentially leading to serious health complications. The recall affects models distributed worldwide, including across the United States and several countries.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Thoratec LLC or your healthcare provider for instructions. Notification method: Letter
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The recall includes CentriMag Blood Pump models REF: 102953, 201-20003, 201-90010, 201-90016, and others. These devices were distributed worldwide, including in 50 states and numerous countries such as Canada and Germany. Units were sold starting in the year prior, with specific models identified in the recall.
The CentriMag Blood Pump may fail to securely lock into the motor using the screw-in locking feature. This malfunction could trigger no alarm for pump insertion failure, leading to serious complications such as stroke, embolism, or even death.
There have been reports of serious incidents linked to this malfunction, including increased heat and anxiety for patients. The exact number of injuries or fatalities has not been disclosed; however, the potential for life-threatening conditions is significant.
Patients and healthcare providers should stop using the CentriMag Blood Pump immediately. They should follow the manufacturer's recall instructions and contact Thoratec LLC for further guidance.
For more information, contact Thoratec LLC directly at their customer service line. Additional details can be found on the FDA's website.
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