PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 24, 2018 Initiated: September 5, 2018 #Z-0103-2019

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.

Details

Recalling Firm
Thoratec Switzerland GMBH
Units Affected
1569
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
Location
Zurich, N/A

Frequently Asked Questions

What product was recalled?
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.. Recalled by Thoratec Switzerland GMBH. Units affected: 1569.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0103-2019.