FDA Device recall Z-1777-2023
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4
- 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 MRI IS1 DF4, Model Number DTPA2D4 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-1777-2023 |
| 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 MRI IS1 DF4, Model Number DTPA2D4; 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 00763000178130, Lot Serial Numbers: RTG605297S, RTG605299S, RTG600588S, RTG601635S, RTG601691S, RTG601840S, RTG60…GTIN 00763000178130, Lot Serial Numbers: RTG605297S, RTG605299S, RTG600588S, RTG601635S, RTG601691S, RTG601840S, RTG601857S, RTG602986S, RTG601966S, RTG601364S, RTG601621S, RTG600270S, RTG600554S, RTG601405S, RTG601699S, RTG601977S, RTG605270S, RTG600137S, RTG600138S, RTG600181S, RTG600271S, RTG600618S, RTG600620S, RTG600621S, RTG600622S, RTG600640S, RTG601395S, RTG601441S, RTG601681S, RTG601783S, RTG601896S, RTG601945S, RTG601948S, RTG602037S, RTG602040S, RTG602042S, RTG602047S, RTG602165S, RTG602166S, RTG602167S, RTG602340S, RTG605614S, RTG602039S, RTG602228S, RTG602306S, RTG602477S, RTG605996S, RTG605997S, RTG604903S, RTG600228S, RTG600332S, RTG601906S, RTG602441S, RTG605330S, RTG605332S, RTG605838S, RTG601643S, RTG606091S, RTG600317S, RTG600255S, RTG600467S, RTG604871S, RTG605042S, RTG605051S, RTG606010S, RTG601452S, RTG602204S, RTG604466S, RTG600411S, RTG600412S, RTG600465S, RTG600517S, RTG602559S, RTG602561S, RTG602563S, RTG602565S, RTG602566S, RTG602569S, RTG602571S, RTG602573S |
|---|
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-1777-2023%22
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