FDA Device recall Z-1812-2023
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1 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-1812-2023 |
| 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 DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF60…GTIN 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF603522S, CWF602774S, CWF605900S, CWF600919S, CWF600938S, CWF601256S, CWF601551S, CWF601593S, CWF601753S, CWF601934S, CWF601936S, CWF602109S, CWF602581S, CWF602772S, CWF603413S, CWF603447S, CWF605891S, CWF602270S, CWF602324S, CWF602338S, CWF602553S, CWF602554S, CWF602674S, CWF602675S, CWF602677S, CWF602751S, CWF602752S, CWF602816S, CWF602823S, CWF602996S, CWF602998S, CWF603000S, CWF603013S, CWF603171S, CWF603174S, CWF603319S, CWF603361S, CWF603362S, CWF603363S, CWF603393S, CWF603406S, CWF603408S, CWF603718S, CWF603720S, CWF603721S, CWF603829S, CWF603830S, CWF603831S, CWF603832S, CWF603925S, CWF603931S, CWF603944S, CWF603996S, CWF603999S, CWF604002S, CWF604003S, CWF604004S, CWF604007S, CWF604008S, CWF604010S, CWF604598S, CWF604686S, CWF604814S, CWF604816S, CWF606151S, CWF606180S, CWF601291S, CWF601561S, CWF601672S, CWF601977S, CWF602155S, CWF606035S, CWF601562S, CWF601736S |
|---|
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-1812-2023%22
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