FDA Device recall Z-1725-2023
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1 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-1725-2023 |
| 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 COBALT DR MRI IS1 DF1, Model Number DDPB3D1; 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 00763000178376, Lot Serial Numbers: RSN600341S, RSN601060S, RSN601316S, RSN601817S, RSN602193S, RSN600668S, RSN60…GTIN 00763000178376, Lot Serial Numbers: RSN600341S, RSN601060S, RSN601316S, RSN601817S, RSN602193S, RSN600668S, RSN600669S, RSN600670S, RSN600672S, RSN601804S, RSN601808S, RSN601810S, RSN602514S, RSN601050S, RSN601241S, RSN602551S, RSN600820S, RSN603061S, RSN601870S, RSN602495S, RSN601384S, RSN601691S, RSN601237S, RSN602951S, RSN603065S, RSN600626S, RSN600877S, RSN601019S, RSN601020S, RSN601022S, RSN601027S, RSN601028S, RSN601029S, RSN601030S, RSN601032S, RSN601038S, RSN601040S, RSN600997S, RSN601013S, RSN601039S, RSN600837S, RSN601913S, RSN601957S, RSN600334S, RSN600116S, RSN602781S, RSN602004S, RSN602073S, RSN601983S, RSN600628S, RSN601374S, RSN600624S, RSN601004S, RSN601902S, RSN602210S, RSN600402S, RSN600359S, RSN600360S, RSN600361S, RSN600366S, RSN601283S, RSN602071S, RSN602182S, RSN602365S, RSN602756S, RSN602171S, RSN600482S, RSN600870S, RSN601950S, RSN602490S, RSN600952S, RSN602026S, RSN602072S, RSN602244S, RSN602297S, RSN600640S, RSN601351S, RSN601352S, RSN601830S, RSN601831S |
|---|
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-1725-2023%22
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