FDA Device recall Z-1809-2023
ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4 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-1809-2023 |
| 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 DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; 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 00643169720558, Lot Serial Numbers: PKZ212063H, PKZ212047H, PKZ212048H, PKZ212049H, PKZ212050H, PKZ212055H, PKZ21…GTIN 00643169720558, Lot Serial Numbers: PKZ212063H, PKZ212047H, PKZ212048H, PKZ212049H, PKZ212050H, PKZ212055H, PKZ212061H, PKZ212062H, PKZ212042H, PKZ212039H, PKZ212041H, PKZ212027H, PKZ212032H, PKZ212033H, PKZ212035H, PKZ212044H, PKZ212053H, PKZ212054H, PKZ212056H, PKZ212057H |
|---|
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-1809-2023%22
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