FDA Device recall Z-1779-2023
CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ 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-1779-2023 |
| 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
CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; 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 00763000178093, Lot Serial Numbers: RTC605498S, RTC605500S, RTC605501S, RTC605502S, RTC607884S, RTC607885S, RTC60…GTIN 00763000178093, Lot Serial Numbers: RTC605498S, RTC605500S, RTC605501S, RTC605502S, RTC607884S, RTC607885S, RTC608196S, RTC608199S, RTC608200S, RTC610884S, RTC610885S, RTC610887S, RTC610889S, RTC610890S, RTC610892S, RTC626989S, RTC626991S, RTC626992S, RTC626996S, RTC604820S, RTC605664S, RTC606411S, RTC606605S, RTC613019S, RTC613629S, RTC614078S, RTC612708S, RTC614277S, RTC611123S, RTC611127S, RTC611128S, RTC613158S, RTC613159S, RTC613160S, RTC613162S, RTC613164S, RTC613165S, RTC613166S, RTC626776S, RTC626778S, RTC626780S, RTC612365S, RTC612540S, RTC612629S, RTC614220S, RTC600235S, RTC600300S, RTC600381S, RTC600573S, RTC602541S, RTC602726S, RTC605274S, RTC605795S, RTC607215S, RTC607469S, RTC608981S, RTC609490S, RTC610107S, RTC610867S, RTC613560S, RTC614081S, RTC600433S, RTC600555S, RTC600556S, RTC600576S, RTC600703S, RTC604519S, RTC605238S, RTC605983S, RTC606093S, RTC606096S, RTC607001S, RTC607069S, RTC607165S, RTC607228S, RTC607497S, RTC609933S, RTC609934S, RTC614263S, RTC616913S |
|---|
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-1779-2023%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.