FDA Device recall Z-1267-2022
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4
- FDA Device
- Class II
- ongoing
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1267-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-12 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; h) Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Reason
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Identifiers
| code_info | a) Cobalt XT VR: DVPA2D1, DVPA2D4: Model DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600175S, RSC600169S, RSC…a) Cobalt XT VR: DVPA2D1, DVPA2D4: Model DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600175S, RSC600169S, RSC600211S, RSC600163S, RSC600177S, RSC600212S, RSC600237S, RSC600217S, RSC601072S, RSC601241S, RSC601396S, RSC600327S, RSC600018S, RSC600347S, RSC600391S, RSC600419S, RSC601490S, RSC600423S, RSC600501S, RSC600337S, RSC600422S, RSC600420S, RSC600421S, RSC601410S, RSC601433S, RSC600281S, RSC600298S, RSC600131S, RSC601388S, RSC600174S, RSC600331S, RSC600240S, RSC600225S, RSC600299S, RSC600328S, RSC600293S, RSC601071S, RSC601345S, RSC601443S, RSC601450S, RSC601419S, RSC600417S, RSC600147S, RSC600275S, RSC601486S, RSC601313S, RSC601317S, RSC601542S, RSC601500S, RSC601520S, RSC600443S, RSC601244S, RSC601107S, RSC601515S, RSC601506S, RSC601231S, RSC601230S, RSC601229S, RSC601228S, RSC601227S, RSC601223S, RSC601222S, RSC601221S, RSC601216S, RSC601175S, RSC601422S, RSC601368S, RSC601366S, RSC601183S, RSC601106S, RSC601022S, RSC601510S, RSC601459S, RSC601554S, RSC601551S, RSC60154 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2022%22
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