FDA Device recall Z-1704-2023
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1 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-1704-2023 |
| 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 DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; 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 00643169720404, Lot Serial Numbers: BWC242988H, BWC241999H, BWC242338H, BWC242392H, BWC243112H, BWC243417H, BWC24…GTIN 00643169720404, Lot Serial Numbers: BWC242988H, BWC241999H, BWC242338H, BWC242392H, BWC243112H, BWC243417H, BWC243633H, BWC243786H, BWC244004H, BWC241880H, BWC242816H, BWC243834H, BWC241861H, BWC242999H, BWC241742H, BWC241891H, BWC241930H, BWC242022H, BWC242027H, BWC242157H, BWC242236H, BWC242463H, BWC242464H, BWC242466H, BWC242482H, BWC242567H, BWC242583H, BWC242645H, BWC242697H, BWC242718H, BWC242721H, BWC242804H, BWC242997H, BWC243009H, BWC243043H, BWC243095H, BWC243211H, BWC243216H, BWC243245H, BWC243258H, BWC243378H, BWC243488H, BWC243489H, BWC243590H, BWC243657H, BWC243711H, BWC243743H, BWC243863H, BWC244033H, BWC244161H, BWC244282H, BWC244431H, BWC242166H, BWC242897H, BWC243484H, BWC243570H, BWC244218H, BWC244438H, BWC241690H, BWC242739H, BWC243166H, BWC243372H, BWC243918H, BWC241761H, BWC243769H, BWC241692H, BWC242218H, BWC242258H, BWC242430H, BWC242496H, BWC242627H, BWC243113H, BWC243183H, BWC243398H, BWC243422H, BWC243536H, BWC243559H, BWC244411H, BWC244490H, BWC242381H |
|---|
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-1704-2023%22
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