FDA Device recall Z-1778-2023
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1
- 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 DF1, Model Number DTPA2Q1 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-1778-2023 |
| 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 DF1, Model Number DTPA2Q1; 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 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD60…GTIN 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD602419S, RTD601286S, RTD600407S, RTD600686S, RTD600687S, RTD600688S, RTD600689S, RTD601807S, RTD602096S, RTD602321S, RTD601977S, RTD600375S, RTD600427S, RTD600818S, RTD601290S, RTD601294S, RTD601304S, RTD603210S, RTD601610S, RTD601791S, RTD600469S, RTD601931S, RTD601498S, RTD601499S, RTD601778S, RTD602158S, RTD602232S, RTD602015S, RTD602249S, RTD603182S, RTD601298S, RTD600498S, RTD603371S, RTD600756S, RTD602093S, RTD601471S, RTD601517S, RTD601525S, RTD601526S, RTD601532S, RTD601534S, RTD601535S, RTD601551S, RTD601552S, RTD601843S, RTD601844S, RTD601846S, RTD601849S, RTD601851S, RTD601852S, RTD601853S, RTD601855S, RTD601857S, RTD601858S, RTD601859S, RTD601861S, RTD601862S, RTD601878S, RTD601895S, RTD601907S, RTD601913S, RTD601914S, RTD601915S, RTD601916S, RTD601933S, RTD601935S, RTD601936S, RTD601937S, RTD601942S, RTD601985S, RTD602052S, RTD602053S, RTD602054S, RTD602055S |
|---|
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-1778-2023%22
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