FDA Device recall Z-1487-2022
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4
- FDA Device
- Class I
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class I recall of Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1487-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-22 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Reason
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Identifiers
| code_info | a. Model Numbers: DVPB3D1: GTIN 00763000178499, Serial Numbers: RSE600212S, RSE600229S, RSE600406S, RSE600450S, RSE6…a. Model Numbers: DVPB3D1: GTIN 00763000178499, Serial Numbers: RSE600212S, RSE600229S, RSE600406S, RSE600450S, RSE600505S, RSE600518S, RSE600519S, RSE600520S, RSE600538S, RSE600539S, RSE600621S, RSE600676S, RSE600681S, RSE600709S, RSE600715S, RSE600716S, RSE600717S, RSE600718S, RSE600725S, RSE600748S, RSE600756S, RSE600768S, RSE601500S, RSE601523S, RSE601579S, RSE601590S, RSE601603S, RSE601702S, RSE601705S, RSE601716S, RSE601718S, RSE601729S, RSE601746S, RSE601747S, RSE601768S, RSE601774S, RSE601780S, RSE601791S, RSE601802S, RSE601819S, RSE601828S, RSE601835S, RSE601841S, RSE601846S, RSE601857S, RSE601879S, RSE601885S, RSE601889S, RSE601890S, RSE601894S, RSE601899S, RSE601900S, RSE601906S, RSE601910S, RSE601914S, RSE601930S, RSE601935S, RSE601936S, RSE601937S, RSE601939S, RSE601940S, RSE601941S, RSE601945S, RSE601947S, RSE601952S, RSE601959S, RSE601965S, RSE602046S, RSE602047S, RSE602048S, RSE602049S, RSE602053S, RSE602060S, RSE602063S, RSE602064S, RSE602067S, RSE602081S, RSE602086 |
|---|
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-1487-2022%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.