FDA Device recall Z-0926-2021
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resyn…
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resyn… by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0926-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-15 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | GA, NJ, PA |
Product
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
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Identifiers
| code_info | Serial Numbers: RTK602501S, RTK602506S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.