FDA Device recall Z-1707-2023
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1 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-1707-2023 |
| 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 DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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 00643169217911, Lot Serial Numbers: BWE613480S, BWE613110S, BWE613432S, BWE613202S, BWE613100S, BWE613096S, BWE61…GTIN 00643169217911, Lot Serial Numbers: BWE613480S, BWE613110S, BWE613432S, BWE613202S, BWE613100S, BWE613096S, BWE613185S, BWE613258S, BWE613431S, BWE612802S, BWE612865S, BWE613214S, BWE613235S, BWE612884S, BWE612956S, BWE613098S, BWE613122S, BWE613143S, BWE613171S, BWE613212S, BWE613216S, BWE613251S, BWE613470S, BWE613162S, BWE613238S, BWE613459S, BWE613430S, BWE613153S, BWE613484S, BWE613168S, BWE612948S, BWE612950S, BWE612970S, BWE613487S, BWE613090S, BWE613224S, BWE613180S, BWE613077S, BWE612815S, BWE612940S, BWE613086S, BWE612721S, BWE613194S, BWE612880S, BWE613125S, BWE613221S, BWE612822S, BWE612985S, BWE612928S, BWE613446S, BWE612939S, BWE612837S, BWE613097S, BWE613095S, BWE613104S, BWE613211S, BWE613463S, BWE613460S, BWE612679S, BWE612960S, BWE613149S, BWE613150S, BWE613247S, BWE612981S, BWE612987S, BWE613145S, BWE613147S, BWE613485S, BWE612986S, BWE613443S, BWE612844S, BWE612686S, BWE612824S, BWE612853S, BWE612923S, BWE612976S, BWE612935S, BWE612982S, BWE612993S, BWE613155S |
|---|
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-1707-2023%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.