FDA Device recall Z-1800-2023
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4 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-1800-2023 |
| 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 DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; 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 00643169720442, Lot Serial Numbers: BWL206052H, BWL205879H, BWL206062H, BWL206106H, BWL206057H, BWL206066H, BWL20…GTIN 00643169720442, Lot Serial Numbers: BWL206052H, BWL205879H, BWL206062H, BWL206106H, BWL206057H, BWL206066H, BWL206087H, BWL205882H, BWL206049H, BWL206050H, BWL206053H, BWL206055H, BWL206059H, BWL206069H, BWL206073H, BWL206074H, BWL206078H, BWL206079H, BWL206081H, BWL206082H, BWL206083H, BWL206084H, BWL206101H, BWL206104H, BWL206110H, BWL206112H, BWL206116H, BWL206118H, BWL206120H, BWL206122H, BWL206123H, BWL206126H, BWL206127H, BWL206068H, BWL206071H, BWL206092H, BWL206093H, BWL206094H, BWL206109H, BWL206117H, BWL206119H, BWL206097H, BWL205878H, BWL206098H, BWL206063H, BWL206114H, BWL206108H, BWL206048H, BWL206064H, BWL206058H, BWL206086H, BWL206099H, BWL206076H, BWL206103H, BWL206107H, BWL206124H, BWL206125H, BWL206105H, BWL206051H, BWL206054H; GTIN 00643169720459, Lot Serial Numbers: BWL606762S, BWL606799S, BWL609508S, BWL606741S, BWL607597S, BWL607510S, BWL607234S, BWL606748S, BWL607162S, BWL607513S, BWL607947S, BWL606791S, BWL607876S, BWL606995S, BWL607071S, BWL606857S, BWL |
|---|
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-1800-2023%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.