FDA Device recall Z-1823-2023
ICD CROME VR MRI DF4, Model Number DVPC3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD CROME VR MRI DF4, Model Number DVPC3D4 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-1823-2023 |
| 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 CROME VR MRI DF4, Model Number DVPC3D4; 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 00763000178550. Lot Serial Numbers: RSH600068S, RSH600173S, RSH600239S, RSH601126S, RSH601127S, RSH601883S, RSH60…GTIN 00763000178550. Lot Serial Numbers: RSH600068S, RSH600173S, RSH600239S, RSH601126S, RSH601127S, RSH601883S, RSH601888S, RSH601444S, RSH601463S, RSH601537S, RSH601538S, RSH600064S, RSH600099S, RSH600174S, RSH600175S, RSH600228S, RSH600275S, RSH600276S, RSH600889S, RSH600903S, RSH601415S, RSH601522S, RSH601873S, RSH600071S, RSH600906S, RSH600922S, RSH601034S, RSH601041S, RSH601123S, RSH600007S, RSH600082S, RSH600110S, RSH601765S, RSH601894S, RSH600236S, RSH600264S, RSH601531S, RSH600057S, RSH600124S, RSH600181S, RSH600211S, RSH600827S, RSH600887S, RSH601024S, RSH601036S, RSH601366S, RSH600902S, RSH601519S, RSH601520S, RSH601751S, RSH601753S, RSH601754S, RSH601805S, RSH600814S, RSH601139S, RSH601355S, RSH601407S, RSH600147S, RSH600101S, RSH601443S, RSH601460S, RSH601462S, RSH601535S, RSH601536S, RSH601539S, RSH601542S, RSH600041S, RSH600045S, RSH600055S, RSH600066S, RSH600067S, RSH600086S, RSH600097S, RSH600102S, RSH600103S, RSH600108S, RSH600109S, RSH600117S, RSH600126S, RSH600130S |
|---|
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-1823-2023%22
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