FDA Device recall Z-1715-2023
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1 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-1715-2023 |
| 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 DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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 00643169837737, Lot Serial Numbers: CWC602314S, CWC602130S, CWC601890S, CWC607466S, CWC602236S, CWC602359S, CWC60…GTIN 00643169837737, Lot Serial Numbers: CWC602314S, CWC602130S, CWC601890S, CWC607466S, CWC602236S, CWC602359S, CWC608108S, CWC607103S, CWC601544S, CWC601546S, CWC605273S, CWC602965S, CWC604941S, CWC605039S, CWC601687S, CWC601688S, CWC602560S, CWC602845S, CWC603176S, CWC603372S, CWC603584S, CWC603596S, CWC603780S, CWC603826S, CWC603862S, CWC604054S, CWC604145S, CWC604909S, CWC605061S, CWC605800S, CWC607271S, CWC607272S, CWC607475S, CWC608775S, CWC608917S, CWC608956S, CWC608480S, CWC608488S, CWC603831S, CWC604086S, CWC604166S, CWC604240S, CWC604391S, CWC604670S, CWC604681S, CWC604684S, CWC604846S, CWC604847S, CWC605090S, CWC605290S, CWC605410S, CWC605411S, CWC605588S, CWC605600S, CWC605863S, CWC605864S, CWC605867S, CWC605876S, CWC605988S, CWC605989S, CWC606354S, CWC606357S, CWC606358S, CWC606521S, CWC606523S, CWC606525S, CWC606527S, CWC606528S, CWC606529S, CWC606531S, CWC606939S, CWC606942S, CWC607001S, CWC607022S, CWC607619S, CWC607630S, CWC607631S, CWC607635S, CWC604643S, CWC605193S |
|---|
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-1715-2023%22
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