Home / Recalls / Thoratec Switzerland GMBH / Z-0103-2019

Z-0103-2019 Class II Terminated

Recalled by Thoratec Switzerland GMBH — Zurich, N/A

Recall Details

Product Type: Devices
Report Date: October 24, 2018
Initiation Date: September 5, 2018
Termination Date: April 28, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1569

Product Description

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

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 Pattern

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

Code Information

UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.