FDA Device recall Z-1710-2023
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4 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-1710-2023 |
| 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 DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF20…GTIN 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF206323H, BWF206420H, BWF206376H, BWF206458H, BWF206459H, BWF206430H, BWF206453H, BWF206359H, BWF206478H, BWF206333H, BWF206365H, BWF206370H, BWF206557H, BWF206599H, BWF206607H, BWF206551H, BWF206367H, BWF206396H, BWF206421H, BWF206554H, BWF206355H, BWF206461H, BWF206604H, BWF206371H, BWF206373H, BWF206374H, BWF206378H, BWF206380H, BWF206381H, BWF206383H, BWF206387H, BWF206388H, BWF206390H, BWF206449H, BWF206473H, BWF206474H, BWF206475H, BWF206500H, BWF206526H, BWF206527H, BWF206528H, BWF206529H, BWF206535H, BWF206563H, BWF206565H, BWF206567H, BWF206568H, BWF206573H, BWF206574H, BWF206575H, BWF206597H, BWF206598H, BWF206175H, BWF206419H, BWF206327H, BWF206491H, BWF206496H, BWF206401H, BWF206321H, BWF206334H, BWF206338H, BWF206344H, BWF206432H, BWF206470H, BWF206489H, BWF206507H, BWF206558H, BWF206577H, BWF206583H, BWF206570H, BWF206581H, BWF206342H, BWF206410H, BWF206492H |
|---|
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-1710-2023%22
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