FDA Device recall Z-0927-2021
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therap…
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therap… 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-0927-2021 |
| 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 CRT-D MRI SureScan DTPB2D1, 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: RTP601047S, RTP601055S |
|---|
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-0927-2021%22
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