Thoratec CentriMag Motor Recall Due to Electrical Cable Failure
Thoratec is recalling CentriMag Motors because a wire break or short circuit in the cable can cause the motor to stop.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves a critical medical device failure (motor stop) that poses a significant risk of serious injury to patients relying on circulatory support.
Plain-English summary
Thoratec Switzerland GMBH is recalling the Thoratec CentriMag Motor, Model 102956. This component is used in the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. The recall involves 1,569 units distributed across 41 U.S. states and the District of Columbia.
The recall is due to reports of the circulatory support system motor stopping. This stoppage can be attributed to a break of a wire or a short circuit between wires within the electrical cable where the cable exits the motor cable bend protection. The recall covers all serial numbers until a design change is implemented to make the motor cable more resistant to damage.
Healthcare facilities and users of the affected blood pumping systems should contact Thoratec for instructions on how to address the defect. The UDI for the affected product is 07640135140078.
The recalled product
- Product
- Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
- Manufacturer
- Thoratec Switzerland GMBH
- Category
- Medical Device — Cardiovascular
- Affected units
- 1,569
Distribution
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