FDA Device recall Z-1716-2023
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4 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-1716-2023 |
| 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 DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ20…GTIN 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ202558H, PHZ202949H, PHZ203163H, PHZ204430H, PHZ203645H, PHZ204171H, PHZ204583H, PHZ204585H, PHZ204589H, PHZ204600H, PHZ204629H, PHZ204676H, PHZ204879H, PHZ204932H, PHZ204991H, PHZ205067H, PHZ205076H, PHZ205168H, PHZ205219H, PHZ205254H, PHZ205303H, PHZ204750H, PHZ202687H, PHZ203913H, PHZ203379H, PHZ203419H, PHZ203421H, PHZ203422H, PHZ203423H, PHZ203425H, PHZ203426H, PHZ203427H, PHZ203435H, PHZ203798H, PHZ203805H, PHZ203808H, PHZ203809H, PHZ203811H, PHZ203816H, PHZ203819H, PHZ203820H, PHZ203822H, PHZ203828H, PHZ203829H, PHZ203830H, PHZ203831H, PHZ204440H, PHZ204442H, PHZ204444H, PHZ204445H, PHZ204446H, PHZ204447H, PHZ204448H, PHZ204449H, PHZ204451H, PHZ205205H, PHZ205206H, PHZ205207H, PHZ205208H, PHZ205209H, PHZ205210H, PHZ205211H, PHZ205213H, PHZ205216H, PHZ205244H, PHZ202741H, PHZ203347H, PHZ202606H, PHZ202985H, PHZ203618H, PHZ204288H, PHZ205146H, PHZ202758H, PHZ202806H |
|---|
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-1716-2023%22
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