FDA Device recall Z-1821-2023
ICD COBALT VR MRI DF4, Model Number DVPB3D4
- 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 DF4, Model Number DVPB3D4 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-1821-2023 |
| 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 DF4, Model Number DVPB3D4; 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 00763000178512, Lot Serial Numbers: RSF600012S, RSF600254S, RSF600591S, RSF600655S, RSF600822S, RSF601247S, RSF60…GTIN 00763000178512, Lot Serial Numbers: RSF600012S, RSF600254S, RSF600591S, RSF600655S, RSF600822S, RSF601247S, RSF602653S, RSF603908S, RSF601102S, RSF607914S, RSF605967S, RSF600633S, RSF600649S, RSF600867S, RSF600868S, RSF600869S, RSF600872S, RSF600873S, RSF600874S, RSF600875S, RSF600876S, RSF600878S, RSF600880S, RSF600883S, RSF602930S, RSF602991S, RSF602998S, RSF603002S, RSF603003S, RSF603013S, RSF603018S, RSF603019S, RSF603022S, RSF603026S, RSF603027S, RSF603030S, RSF603032S, RSF603033S, RSF603034S, RSF603035S, RSF603036S, RSF603736S, RSF603737S, RSF603741S, RSF603742S, RSF603744S, RSF603746S, RSF603747S, RSF603749S, RSF603754S, RSF603755S, RSF603756S, RSF603758S, RSF603759S, RSF603762S, RSF603763S, RSF603764S, RSF603799S, RSF603802S, RSF603804S, RSF603806S, RSF603810S, RSF603813S, RSF603818S, RSF603821S, RSF603824S, RSF602665S, RSF602703S, RSF603249S, RSF603648S, RSF603939S, RSF607644S, RSF601171S, RSF601174S, RSF602584S, RSF602743S, RSF600887S, RSF602678S, RSF608130S, RSF600767S |
|---|
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-1821-2023%22
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