Z-0926-2021 Class II Terminated
FDA device recall Z-0926-2021 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on November 15, 2020 and is designated Class II. Reason for recall: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. The recall status is terminated (terminated December 23, 2025). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- November 15, 2020
- Termination Date
- December 23, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Reason for Recall
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Distribution Pattern
Distribution to US states of GA, PA, NJ, and France
Code Information
Serial Numbers: RTK602501S, RTK602506S