FDA Device recall Z-1719-2023
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1 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-1719-2023 |
| 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 DDME3D1 MIRRO MRI, Model Number DDME3D1; 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 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS60…GTIN 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS602880S, CWS602742S, CWS602559S, CWS602607S, CWS602433S, CWS602957S, CWS601056S, CWS601348S, CWS601807S, CWS602219S, CWS602422S, CWS602474S, CWS601519S, CWS601425S, CWS601296S, CWS602918S, CWS600483S, CWS600490S, CWS600494S, CWS600607S, CWS600960S, CWS601001S, CWS601199S, CWS601460S, CWS601594S, CWS601704S, CWS601713S, CWS601790S, CWS600422S, CWS600502S, CWS600125S, CWS600132S, CWS600342S, CWS600571S, CWS601791S, CWS600172S, CWS600318S, CWS600423S, CWS600453S, CWS600464S, CWS600686S, CWS601122S, CWS601155S, CWS601445S, CWS601981S, CWS601465S, CWS601628S, CWS600445S, CWS602676S, CWS600945S, CWS600142S, CWS600147S, CWS600178S, CWS600551S, CWS600557S, CWS600770S, CWS600996S, CWS601094S, CWS601323S, CWS601966S, CWS602181S, CWS602556S, CWS602618S, CWS602879S, CWS601541S, CWS601542S, CWS601203S, CWS601374S, CWS602139S, CWS600458S, CWS600102S, CWS600781S, CWS600759S, CWS600764S |
|---|
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-1719-2023%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.