FDA Device recall Z-1819-2023
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD COBALT XT VR MRI DF4, Model Number DVPA2D4 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-1819-2023 |
| 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 XT VR MRI DF4, Model Number DVPA2D4; 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 00763000178468. Lot Serial numbers: RSD605765S, RSD605767S, RSD607880S, RSD607881S, RSD607886S, RSD607890S, RSD60…GTIN 00763000178468. Lot Serial numbers: RSD605765S, RSD605767S, RSD607880S, RSD607881S, RSD607886S, RSD607890S, RSD603551S, RSD603552S, RSD603553S, RSD603554S, RSD603555S, RSD600536S, RSD601541S, RSD602283S, RSD602524S, RSD602542S, RSD602924S, RSD603303S, RSD603396S, RSD607136S, RSD608177S, RSD608547S, RSD606272S, RSD607000S, RSD607711S, RSD607712S, RSD602036S, RSD602645S, RSD602659S, RSD603096S, RSD603670S, RSD604815S, RSD608193S, RSD605918S, RSD605919S, RSD605920S, RSD605921S, RSD605922S, RSD605923S, RSD605924S, RSD605926S, RSD605927S, RSD605929S, RSD605930S, RSD605931S, RSD605932S, RSD605933S, RSD604238S, RSD604294S, RSD604312S, RSD604313S, RSD604314S, RSD604614S, RSD604616S, RSD604710S, RSD604721S, RSD604725S, RSD605925S, RSD607788S, RSD607789S, RSD607790S, RSD607791S, RSD607792S, RSD607793S, RSD607794S, RSD607795S, RSD607797S, RSD607800S, RSD607801S, RSD607802S, RSD609083S, RSD609084S, RSD609085S, RSD605068S, RSD608525S, RSD609065S, RSD609066S, RSD609067S, RSD609069S, RSD609071S |
|---|
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-1819-2023%22
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