FDA Device recall Z-1816-2023
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1 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-1816-2023 |
| 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 DVME3D1 MIRRO MRI, Model Number DVME3D1; 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 00763000001605, Lot Serial Numbers: CWP603713S, CWP601986S, CWP600810S, CWP602954S, CWP602169S, CWP602564S, CWP60…GTIN 00763000001605, Lot Serial Numbers: CWP603713S, CWP601986S, CWP600810S, CWP602954S, CWP602169S, CWP602564S, CWP602486S, CWP601838S, CWP600696S, CWP602627S, CWP602315S, CWP602621S, CWP604004S, CWP603407S, CWP603894S, CWP604066S, CWP602233S, CWP603772S, CWP603201S, CWP603888S, CWP602797S, CWP603582S, CWP603254S, CWP603475S, CWP602907S, CWP603605S, CWP603606S, CWP602148S, CWP602999S, CWP601940S, CWP602860S, CWP600692S, CWP600693S, CWP601684S, CWP601750S, CWP602026S, CWP602250S, CWP602395S, CWP600661S, CWP600672S, CWP600673S, CWP601025S, CWP601261S, CWP601303S, CWP601404S, CWP601545S, CWP601730S, CWP601740S, CWP601753S, CWP601912S, CWP602158S, CWP602213S, CWP602504S, CWP602670S, CWP603190S, CWP603321S, CWP603588S, CWP601814S, CWP603269S, CWP600319S, CWP600528S, CWP600165S, CWP600198S, CWP600259S, CWP600347S, CWP600382S, CWP600924S, CWP601414S, CWP601449S, CWP601852S, CWP602821S, CWP602897S, CWP602949S, CWP602991S, CWP604050S, CWP601592S, CWP600897S, CWP602865S, CWP600265S, CWP600261S |
|---|
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-1816-2023%22
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