Z-0103-2019 Class II Terminated
FDA device recall Z-0103-2019 was initiated by Thoratec Switzerland GMBH on Sep 5, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 28, 2021). Affected quantity: 1569.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2018
- Initiation Date
- Sep 5, 2018
- Termination Date
- Apr 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0103-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026