FDA Device recall Z-1820-2023
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1820-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
Reason
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Identifiers
| code_info | GTIN 00763000178499, Lot Serial Numbers: RSE600116S, RSE600346S, RSE600428S, RSE600572S, RSE600505S, RSE600512S, RSE60…GTIN 00763000178499, Lot Serial Numbers: RSE600116S, RSE600346S, RSE600428S, RSE600572S, RSE600505S, RSE600512S, RSE600513S, RSE600515S, RSE600517S, RSE600518S, RSE600519S, RSE600520S, RSE601603S, RSE601609S, RSE601846S, RSE601849S, RSE601856S, RSE601872S, RSE601873S, RSE602612S, RSE600806S, RSE601469S, RSE600412S, RSE600554S, RSE602156S, RSE602245S, RSE602658S, RSE601353S, RSE600764S, RSE602060S, RSE600993S, RSE602062S, RSE602445S, RSE600734S, RSE601371S, RSE602291S, RSE602297S, RSE600746S, RSE601898S, RSE602099S, RSE600431S, RSE600674S, RSE601618S, RSE601619S, RSE601620S, RSE601621S, RSE601622S, RSE600190S, RSE600193S, RSE601209S, RSE601330S, RSE601355S, RSE601504S, RSE600672S, RSE602161S, RSE601259S, RSE602483S, RSE602484S, RSE600831S, RSE601521S, RSE602381S, RSE600466S, RSE602661S, RSE601694S, RSE602144S, RSE601665S, RSE600452S, RSE601575S, RSE602255S, RSE600158S, RSE601717S, RSE601721S, RSE601724S, RSE600285S, RSE601560S, RSE601774S, RSE601962S, RSE602295S, RSE600579S, RSE602177S |
|---|
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-1820-2023%22
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