FDA Device recall Z-1712-2023
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4 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-1712-2023 |
| 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 DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; 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 00643169720497, Lot Serial Numbers: PFZ236436H, PFZ242339H, PFZ247708H, PFZ247891H, PFZ250783H, PFZ252117H, PFZ25…GTIN 00643169720497, Lot Serial Numbers: PFZ236436H, PFZ242339H, PFZ247708H, PFZ247891H, PFZ250783H, PFZ252117H, PFZ259560H, PFZ265053H, PFZ271895H, PFZ248688H, PFZ254957H, PFZ260373H, PFZ273832H, PFZ244136H, PFZ245315H, PFZ264212H, PFZ271087H, PFZ273388H, PFZ238454H, PFZ242886H, PFZ245032H, PFZ245482H, PFZ251539H, PFZ251620H, PFZ254361H, PFZ256071H, PFZ258481H, PFZ259582H, PFZ261497H, PFZ263430H, PFZ264999H, PFZ268418H, PFZ269828H, PFZ274151H, PFZ236422H, PFZ239293H, PFZ240140H, PFZ242722H, PFZ244519H, PFZ244850H, PFZ246467H, PFZ247093H, PFZ248638H, PFZ250072H, PFZ250429H, PFZ251666H, PFZ263854H, PFZ268573H, PFZ268973H, PFZ240263H, PFZ242174H, PFZ247965H, PFZ263650H, PFZ268685H, PFZ270530H, PFZ240280H, PFZ240282H, PFZ240283H, PFZ240284H, PFZ240285H, PFZ240286H, PFZ240287H, PFZ240288H, PFZ240292H, PFZ240294H, PFZ240295H, PFZ240296H, PFZ245429H, PFZ245430H, PFZ245435H, PFZ245437H, PFZ253305H, PFZ253306H, PFZ253312H, PFZ253315H, PFZ253317H, PFZ253318H, PFZ256364H, PFZ256365H, PFZ256366H |
|---|
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-1712-2023%22
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