FDA Device recall Z-1718-2023
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4 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-1718-2023 |
| 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 DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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 00763000001506, Lot Serial Numbers: CWN606940S, CWN606941S, CWN606806S, CWN609866S, CWN607173S, CWN607174S, CWN60…GTIN 00763000001506, Lot Serial Numbers: CWN606940S, CWN606941S, CWN606806S, CWN609866S, CWN607173S, CWN607174S, CWN606850S, CWN605016S, CWN605224S, CWN605226S, CWN602473S, CWN605696S, CWN606066S, CWN601517S, CWN610794S, CWN611698S, CWN611709S, CWN611042S, CWN611699S, CWN608530S, CWN611057S, CWN611194S, CWN611137S, CWN611173S, CWN611168S, CWN610989S, CWN610994S, CWN610999S, CWN608676S, CWN610063S, CWN608932S, CWN609322S, CWN610602S, CWN608143S, CWN610351S, CWN611528S, CWN611651S, CWN607995S, CWN611583S, CWN608694S, CWN611439S, CWN611468S, CWN611541S, CWN611395S, CWN608844S, CWN611563S, CWN611417S, CWN608827S, CWN608184S, CWN608185S, CWN607983S, CWN609341S, CWN612034S, CWN610308S, CWN609462S, CWN608691S, CWN611586S, CWN611558S, CWN611650S, CWN611477S, CWN611385S, CWN611576S, CWN608837S, CWN608405S, CWN610408S, CWN611574S, CWN611547S, CWN611599S, CWN611554S, CWN603401S, CWN603403S, CWN603404S, CWN603405S, CWN603407S, CWN603408S, CWN603409S, CWN603516S, CWN603517S, CWN603518S, CWN603521S |
|---|
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-1718-2023%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.