FDA Device recall Z-1708-2023
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4 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-1708-2023 |
| 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 DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; 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 00643169217928, Lot Serial Numbers: BWD609356S, BWD609450S, BWD609318S, BWD609387S, BWD609454S, BWD609558S, BWD60…GTIN 00643169217928, Lot Serial Numbers: BWD609356S, BWD609450S, BWD609318S, BWD609387S, BWD609454S, BWD609558S, BWD609464S, BWD609549S, BWD609355S, BWD609467S, BWD609389S, BWD609343S, BWD609397S, BWD609567S, BWD609395S, BWD609462S, BWD609470S, BWD609316S, BWD609554S, BWD609551S, BWD609594S, BWD609391S, BWD609466S, BWD609560S, BWD609473S, BWD609288S, BWD609322S, BWD609352S, BWD609360S, BWD609465S, BWD609476S, BWD609547S, BWD609363S, BWD609472S, BWD609573S, BWD609319S, BWD609526S, BWD609570S, BWD609448S, BWD609370S, BWD609320S, BWD609367S, BWD609317S, BWD609368S, BWD609371S, BWD609385S, BWD609362S, BWD609373S, BWD609381S, BWD609346S, BWD609574S, BWD609572S, BWD609365S, BWD609357S, BWD609348S, BWD609451S, BWD609568S, BWD609386S, BWD609344S, BWD609468S, BWD609559S, BWD609569S, BWD609342S, BWD609347S, BWD609353S, BWD609566S, BWD609374S, BWD609453S, BWD609361S, BWD609459S, BWD609460S, BWD609392S, BWD609553S, BWD609562S, BWD609359S, BWD609345S, BWD609366S, BWD609384S, BWD609455S, BWD609399S |
|---|
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-1708-2023%22
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