FDA Device recall Z-1705-2023
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4 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-1705-2023 |
| 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 DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; 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 00643169720374, Lot Serial Numbers: BWB231977H, BWB232204H, BWB231981H, BWB231888H, BWB232232H, BWB232076H, BWB23…GTIN 00643169720374, Lot Serial Numbers: BWB231977H, BWB232204H, BWB231981H, BWB231888H, BWB232232H, BWB232076H, BWB231876H, BWB231908H, BWB231979H, BWB232244H, BWB232310H, BWB231918H, BWB232114H, BWB231867H, BWB232361H, BWB231879H, BWB231847H, BWB232311H, BWB232048H, BWB231915H, BWB232272H, BWB232281H, BWB232164H, BWB232142H, BWB232316H, BWB232027H, BWB232321H, BWB231976H, BWB232046H, BWB232357H, BWB232185H, BWB232233H, BWB232334H, BWB232378H, BWB232411H, BWB232049H, BWB232218H, BWB232097H, BWB232326H, BWB232156H, BWB231855H, BWB231858H, BWB232032H, BWB232106H, BWB232015H, BWB232260H, BWB232284H, BWB232328H, BWB232059H, BWB232018H, BWB232037H, BWB232043H, BWB232092H, BWB232112H, BWB232125H, BWB232144H, BWB232175H, BWB232179H, BWB232181H, BWB232190H, BWB232216H, BWB232237H, BWB232340H, BWB232369H, BWB232410H, BWB232414H, BWB231927H, BWB232056H, BWB232071H, BWB232087H, BWB232121H, BWB232250H, BWB232403H, BWB232039H, BWB232123H, BWB232124H, BWB231865H, BWB232128H, BWB232152H, BWB231939H |
|---|
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-1705-2023%22
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