FDA Device recall Z-1709-2023
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1 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-1709-2023 |
| 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-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG20…GTIN 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG208301H, BWG208376H, BWG208406H, BWG208412H, BWG208520H, BWG208539H, BWG208652H, BWG208716H, BWG208296H, BWG208340H, BWG208484H, BWG208220H, BWG208234H, BWG208641H, BWG208702H, BWG208758H, BWG208430H, BWG208206H, BWG208215H, BWG208561H, BWG208216H, BWG208705H, BWG208502H, BWG208221H, BWG208236H, BWG208488H, BWG208403H, BWG208312H, BWG208557H, BWG208335H, BWG208530H, BWG208634H, BWG208745H, BWG208746H, BWG208249H, BWG208654H, BWG208291H, BWG208515H, BWG208596H, BWG208636H, BWG208637H, BWG208730H, BWG208757H, BWG208213H, BWG208347H, BWG208597H, BWG208605H, BWG208692H, BWG208514H, BWG208640H, BWG208326H, BWG208499H, BWG208223H, BWG208491H, BWG208541H, BWG208573H, BWG208304H, BWG208323H, BWG208345H, BWG208370H, BWG208672H, BWG208250H, BWG208270H, BWG208346H, BWG208389H, BWG208482H, BWG208494H, BWG208495H, BWG208497H, BWG208498H, BWG208521H, BWG208547H, BWG208396H, BWG208799H |
|---|
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-1709-2023%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.