FDA Device recall Z-1817-2023
ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4 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-1817-2023 |
| 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-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; 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 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR61…GTIN 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR613808S, CWR600732S, CWR606430S, CWR602651S, CWR607356S, CWR610310S, CWR604045S, CWR603303S, CWR609623S, CWR605872S, CWR601687S, CWR603211S, CWR602807S, CWR607694S, CWR613692S, CWR613696S, CWR605094S, CWR610428S, CWR606832S, CWR607019S, CWR612869S, CWR614166S, CWR614552S, CWR608782S, CWR611713S, CWR614839S, CWR613888S, CWR614119S, CWR614102S, CWR614110S, CWR613089S, CWR612399S, CWR608766S, CWR614937S, CWR612224S, CWR614130S, CWR612786S, CWR614153S, CWR613324S, CWR612299S, CWR612283S, CWR612754S, CWR610251S, CWR610659S, CWR604739S, CWR605422S, CWR605753S, CWR606253S, CWR607872S, CWR609650S, CWR613342S, CWR606875S, CWR601224S, CWR601549S, CWR601550S, CWR602194S, CWR603281S, CWR603711S, CWR604836S, CWR605024S, CWR605378S, CWR606857S, CWR609093S, CWR600564S, CWR601374S, CWR601412S, CWR602016S, CWR602048S, CWR602172S, CWR602215S, CWR602229S, CWR602850S, CWR604727S, CWR604841S |
|---|
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-1817-2023%22
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