FDA Device recall Z-1774-2023
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1
- 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 DF1, Model Number DTPA2D1 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-1774-2023 |
| 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 DF1, Model Number DTPA2D1; 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 00763000178147, Lot Serial numbers: RTH601483S, RTH602021S, RTH602022S, RTH602302S, RTH602303S, RTH602305S, RTH60…GTIN 00763000178147, Lot Serial numbers: RTH601483S, RTH602021S, RTH602022S, RTH602302S, RTH602303S, RTH602305S, RTH602306S, RTH605169S, RTH602089S, RTH603993S, RTH601526S, RTH600467S, RTH600514S, RTH600533S, RTH600607S, RTH600608S, RTH601387S, RTH601543S, RTH601544S, RTH601545S, RTH602017S, RTH605116S, RTH600520S, RTH602108S, RTH604790S, RTH602149S, RTH605081S, RTH605082S, RTH604360S, RTH604780S, RTH604943S, RTH604734S, RTH600153S, RTH601390S, RTH601395S, RTH601849S, RTH601868S, RTH602192S, RTH602619S, RTH600554S, RTH602035S, RTH602694S, RTH600170S, RTH602206S, RTH601611S, RTH602091S, RTH602195S, RTH603628S, RTH600220S, RTH600223S, RTH600228S, RTH600288S, RTH601447S, RTH601448S, RTH601449S, RTH601450S, RTH602055S, RTH602056S, RTH602057S, RTH602058S, RTH602059S, RTH602060S, RTH602061S, RTH602064S, RTH602065S, RTH602067S, RTH602069S, RTH602071S, RTH602072S, RTH602073S, RTH602074S, RTH602077S, RTH602078S, RTH602079S, RTH602271S, RTH602272S, RTH602276S, RTH602277S, RTH602288S, RTH602625S |
|---|
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-1774-2023%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.