FDA Device recall Z-1798-2023
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4 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-1798-2023 |
| 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 DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; 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 00643169218024, Lot Serial Numbers: BWJ607141S, BWJ607132S, BWJ607040S, BWJ607055S, BWJ607056S, BWJ607025S; GTIN…GTIN 00643169218024, Lot Serial Numbers: BWJ607141S, BWJ607132S, BWJ607040S, BWJ607055S, BWJ607056S, BWJ607025S; GTIN 00643169969575, Lot Serial Numbers: BWJ607007S, BWJ607008S, BWJ607010S, BWJ607011S, BWJ607012S, BWJ607015S, BWJ607020S, BWJ607022S, BWJ607024S, BWJ607029S, BWJ607034S, BWJ607035S, BWJ607037S, BWJ607077S, BWJ607347S, BWJ607043S, BWJ607091S, BWJ607094S, BWJ607095S, BWJ607101S, BWJ607342S, BWJ607343S, BWJ607344S, BWJ606951S, BWJ606991S, BWJ606994S, BWJ607005S, BWJ607060S, BWJ607090S, BWJ607096S, BWJ607097S, BWJ607098S, BWJ607120S, BWJ607121S, BWJ607127S, BWJ607145S, BWJ607146S, BWJ607147S, BWJ607149S, BWJ607156S, BWJ607158S, BWJ607159S, BWJ607160S, BWJ607162S, BWJ607092S, BWJ607093S, BWJ607003S, BWJ607288S, BWJ607280S, BWJ607282S, BWJ607286S, BWJ607287S, BWJ606996S, BWJ606998S, BWJ607016S, BWJ607019S, BWJ607057S, BWJ607061S, BWJ607062S, BWJ607063S, BWJ607074S, BWJ607078S, BWJ607082S, BWJ607084S, BWJ607085S, BWJ607104S, BWJ607105S, BWJ607106S, BWJ607123S, BWJ607124S, BWJ |
|---|
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-1798-2023%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.