FDA Device recall Z-1726-2023
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4
- 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 DF4, Model Number DDPB3D4 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-1726-2023 |
| 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 DF4, Model Number DDPB3D4; 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 00763000178390, Lot Serial Numbers: RSO600207S, RSO600934S, RSO602587S, RSO602860S, RSO603892S, RSO600679S, RSO61…GTIN 00763000178390, Lot Serial Numbers: RSO600207S, RSO600934S, RSO602587S, RSO602860S, RSO603892S, RSO600679S, RSO612257S, RSO602636S, RSO604992S, RSO609567S, RSO609647S, RSO609795S, RSO609900S, RSO610931S, RSO607136S, RSO609278S, RSO601095S, RSO601096S, RSO601098S, RSO601472S, RSO601473S, RSO601474S, RSO601475S, RSO601476S, RSO601477S, RSO601478S, RSO601479S, RSO604357S, RSO604358S, RSO605928S, RSO606135S, RSO606155S, RSO603632S, RSO603681S, RSO607412S, RSO607605S, RSO610650S, RSO600968S, RSO601258S, RSO603258S, RSO603300S, RSO603339S, RSO603742S, RSO603773S, RSO612385S, RSO601910S, RSO601911S, RSO601913S, RSO602604S, RSO602611S, RSO603824S, RSO603826S, RSO603876S, RSO609857S, RSO610204S, RSO609865S, RSO610317S, RSO601050S, RSO601392S, RSO601568S, RSO601741S, RSO604464S, RSO600230S, RSO610679S, RSO612158S, RSO612159S, RSO608401S, RSO608413S, RSO613154S, RSO613155S, RSO609928S, RSO610881S, RSO611808S, RSO600081S, RSO600082S, RSO600083S, RSO600951S, RSO600986S, RSO601604S, RSO604972S |
|---|
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-1726-2023%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.