FDA Device recall Z-1802-2023
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4 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-1802-2023 |
| 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 DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; 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 00763000217891, Lot Serial Numbers: EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS60…GTIN 00763000217891, Lot Serial Numbers: EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S |
|---|
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-1802-2023%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.