FDA Device recall Z-1811-2023
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4 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-1811-2023 |
| 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 DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ61…GTIN 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ613269S, PLZ613270S, PLZ610634S, PLZ612616S, PLZ613234S, PLZ610657S, PLZ611892S, PLZ610319S, PLZ610320S, PLZ610622S, PLZ610625S, PLZ610626S, PLZ610627S, PLZ610631S, PLZ610670S, PLZ610671S, PLZ610672S, PLZ610988S, PLZ610990S, PLZ610992S, PLZ611154S, PLZ611155S, PLZ611159S, PLZ611202S, PLZ611643S, PLZ611644S, PLZ611645S, PLZ611815S, PLZ611819S, PLZ611822S, PLZ611889S, PLZ611890S, PLZ611891S, PLZ610001S, PLZ611744S, PLZ610666S, PLZ613301S, PLZ613302S, PLZ611722S, PLZ611738S, PLZ611741S, PLZ611923S, PLZ612176S, PLZ613231S, PLZ613236S, PLZ613237S, PLZ613250S, PLZ613282S, PLZ613288S, PLZ613298S, PLZ611726S, PLZ611728S, PLZ613246S, PLZ613247S, PLZ613248S, PLZ610991S, PLZ611759S, PLZ611768S, PLZ610684S, PLZ610986S, PLZ610515S, PLZ610989S, PLZ611145S, PLZ611716S, PLZ611116S, PLZ611707S, PLZ611714S, PLZ610471S, PLZ610996S, PLZ613221S, PLZ613223S, PLZ613224S, PLZ613225S, PLZ613226S |
|---|
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-1811-2023%22
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