FDA Device recall Z-1813-2023
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4 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-1813-2023 |
| 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 DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; 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 00643169720596, Lot Serial Numbers: PMZ618802S, PMZ616324S, PMZ616325S, PMZ618783S, PMZ614007S, PMZ616319S, PMZ61…GTIN 00643169720596, Lot Serial Numbers: PMZ618802S, PMZ616324S, PMZ616325S, PMZ618783S, PMZ614007S, PMZ616319S, PMZ616311S, PMZ616317S, PMZ616329S, PMZ614015S, PMZ614036S, PMZ616320S, PMZ613982S, PMZ615518S, PMZ616318S, PMZ616327S, PMZ618780S, PMZ618807S, PMZ618813S, PMZ616312S, PMZ616323S, PMZ618796S, PMZ619084S, PMZ618785S, PMZ616326S, PMZ618798S, PMZ614044S, PMZ612017S, PMZ612853S, PMZ613328S, PMZ613097S, PMZ614065S, PMZ614046S, PMZ613063S, PMZ613316S, PMZ614003S, PMZ614010S, PMZ614033S, PMZ614097S, PMZ613087S, PMZ613201S, PMZ614058S, PMZ614099S, PMZ613212S, PMZ613219S, PMZ613207S, PMZ613206S, PMZ613318S, PMZ613962S, PMZ614002S, PMZ613216S, PMZ613313S, PMZ613073S, PMZ613077S, PMZ613079S, PMZ613082S, PMZ613998S, PMZ613999S, PMZ614000S, PMZ614083S, PMZ614085S, PMZ614087S, PMZ614092S, PMZ614093S, PMZ613078S, PMZ614042S, PMZ613189S, PMZ613098S, PMZ613071S, PMZ613891S, PMZ613892S, PMZ613893S, PMZ613894S, PMZ613895S, PMZ614024S, PMZ614026S, PMZ614027S, PMZ614028S, PMZ614029S, PMZ614060S |
|---|
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-1813-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.