FDA Device recall Z-1720-2023
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4 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-1720-2023 |
| 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 DDME3D4 MIRRO MRI, Model Number DDME3D4; 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 00763000001582, Lot Serial Numbers: CWT605432S, CWT600264S, CWT607420S, CWT607213S, CWT607463S, CWT607388S, CWT60…GTIN 00763000001582, Lot Serial Numbers: CWT605432S, CWT600264S, CWT607420S, CWT607213S, CWT607463S, CWT607388S, CWT607425S, CWT607374S, CWT607359S, CWT601622S, CWT603529S, CWT605876S, CWT605723S, CWT604657S, CWT604666S, CWT605105S, CWT605034S, CWT608381S, CWT608194S, CWT606083S, CWT604306S, CWT606483S, CWT607258S, CWT606731S, CWT605978S, CWT607015S, CWT606443S, CWT607932S, CWT608011S, CWT607139S, CWT606486S, CWT605678S, CWT607017S, CWT607943S, CWT608012S, CWT606735S, CWT606736S, CWT606738S, CWT606739S, CWT606741S, CWT606742S, CWT606743S, CWT606744S, CWT606745S, CWT606746S, CWT606747S, CWT606748S, CWT606749S, CWT606750S, CWT603376S, CWT607308S, CWT602883S, CWT603530S, CWT604069S, CWT604509S, CWT604647S, CWT604878S, CWT605689S, CWT605944S, CWT606036S, CWT600803S, CWT601014S, CWT601028S, CWT601179S, CWT601231S, CWT601422S, CWT602980S, CWT602981S, CWT603019S, CWT603216S, CWT603319S, CWT603320S, CWT604576S, CWT605154S, CWT600275S, CWT601002S, CWT601180S, CWT601388S, CWT601407S, CWT601417S |
|---|
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-1720-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.