FDA Device recall Z-0928-2021
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and B…
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and B… 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-0928-2021 |
| 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 DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with 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: RSN600251S, RSN600656S |
|---|
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-0928-2021%22
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