FDA Device recall Z-1717-2023
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1 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-1717-2023 |
| 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 DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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 00763000001483, Lot Serial Numbers: CWM603134S, CWM600439S, CWM601269S, CWM603840S, CWM603922S, CWM601037S, CWM60…GTIN 00763000001483, Lot Serial Numbers: CWM603134S, CWM600439S, CWM601269S, CWM603840S, CWM603922S, CWM601037S, CWM602990S, CWM603292S, CWM602888S, CWM602567S, CWM604350S, CWM604400S, CWM604147S, CWM604447S, CWM603919S, CWM604293S, CWM603993S, CWM604453S, CWM604276S, CWM603779S, CWM603512S, CWM604434S, CWM604110S, CWM603974S, CWM604303S, CWM604451S, CWM604296S, CWM603643S, CWM604349S, CWM603935S, CWM603697S, CWM603897S, CWM604404S, CWM603551S, CWM601796S, CWM601798S, CWM601800S, CWM601801S, CWM601802S, CWM601905S, CWM601911S, CWM601931S, CWM602000S, CWM602003S, CWM602004S, CWM602005S, CWM602006S, CWM602097S, CWM602098S, CWM602124S, CWM602139S, CWM602709S, CWM602710S, CWM602711S, CWM602823S, CWM602836S, CWM602838S, CWM602847S, CWM602848S, CWM602883S, CWM602898S, CWM603276S, CWM600958S, CWM601164S, CWM601353S, CWM601410S, CWM601640S, CWM601831S, CWM602141S, CWM603581S, CWM603582S, CWM603627S, CWM603628S, CWM604291S, CWM604292S, CWM601211S, CWM601263S, CWM601339S, CWM601506S, CWM601641S |
|---|
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-1717-2023%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.