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FDA (Device enforcement)Recalled 2018-09-05closedclass ii

Thoratec Switzerland GMBH: Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

Is my product affected?

Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

  • UPC 07640135140078

Check against the official notice below — it lists the full affected range.

What happened

Thoratec Switzerland GMBH is recalling the CentriMag Motor (Model 102956), which is a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. The recall was initiated because the motor can stop working due to a wire break or short circuit in the electrical cable at the point where it exits the motor cable bend protection. A total of 1,569 units have been distributed across the United States, and the recall affects all serial numbers until a design change is implemented to make the motor cable more resistant to damage.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

Details from the source

Reason for recall: Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection. Distribution: U.S.: OR, AZ, CA, ID, WA, WI, NY, MA, CT, NJ, ME, RI, IL, MI, TN, OH, IN, KY, IA, AL, FL, NC, GA, SC, VA, MD, DC, PA, WV, DE, MN, MT, NE, CO, NM, UT, AR, MO, MC, TX, OK, LA, MS, ND Quantity: 1569 Lot/code info: UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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