FDA Device recall Z-1713-2023
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1 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-1713-2023 |
| 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 DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; 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 00643169837720, Lot Serial Numbers: CWB609778S, CWB609784S, CWB609523S, CWB603432S, CWB605718S, CWB601752S, CWB60…GTIN 00643169837720, Lot Serial Numbers: CWB609778S, CWB609784S, CWB609523S, CWB603432S, CWB605718S, CWB601752S, CWB601945S, CWB601946S, CWB602803S, CWB605225S, CWB607387S, CWB609714S, CWB605552S, CWB601729S, CWB602371S, CWB603105S, CWB603660S, CWB603852S, CWB604726S, CWB605271S, CWB608325S, CWB609120S, CWB607821S, CWB607823S, CWB607829S, CWB607834S, CWB607881S, CWB607884S, CWB607885S, CWB607886S, CWB608671S, CWB608672S, CWB608675S, CWB608676S, CWB608677S, CWB608678S, CWB608680S, CWB608681S, CWB608683S, CWB608684S, CWB608686S, CWB608687S, CWB608690S, CWB608691S, CWB608692S, CWB608697S, CWB609222S, CWB609930S, CWB609931S, CWB607959S, CWB608041S, CWB608051S, CWB608052S, CWB608055S, CWB608064S, CWB608067S, CWB608068S, CWB608069S, CWB608073S, CWB608074S, CWB608075S, CWB608081S, CWB608084S, CWB608085S, CWB608088S, CWB608089S, CWB608095S, CWB608842S, CWB608843S, CWB608844S, CWB608845S, CWB608847S, CWB608848S, CWB608849S, CWB608851S, CWB608854S, CWB608855S, CWB608856S, CWB608857S, CWB608858S |
|---|
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-1713-2023%22
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