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 CentriMag Blood Pump is designed to provide acute circulatory support in patients requiring ECMO (extracorporeal membrane oxygenation) therapy. Healthcare providers use this device for patients with severe heart or lung failure.
The device may not securely lock into the motor, which can prevent it from functioning properly. This malfunction could cause serious health complications if not addressed immediately.
This recall is not part of a broader industry pattern.
The recall poses significant safety risks to patients relying on this device for life-sustaining support, creating urgency for immediate action.
The model number and serial number can typically be found on the device's labeling or packaging.
Expect a timeline of 4-8 weeks for refund processing once the return is initiated.
Keep records of your purchase, any correspondence with the manufacturer, and photographs of the device for your records.
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.
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