FDA Device recall Z-1723-2023
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4 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-1723-2023 |
| 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 XT DR MRI IS1 DF4, Model Number DDPA2D4; 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 00763000178345, Lot Serial Numbers: RSM612933S, RSM612934S, RSM612935S, RSM621211S, RSM604622S, RSM604623S, RSM60…GTIN 00763000178345, Lot Serial Numbers: RSM612933S, RSM612934S, RSM612935S, RSM621211S, RSM604622S, RSM604623S, RSM608882S, RSM621210S, RSM621212S, RSM612673S, RSM609800S, RSM610899S, RSM619550S, RSM620275S, RSM620130S, RSM615997S, RSM619083S, RSM623383S, RSM623721S, RSM610958S, RSM616552S, RSM614351S, RSM618224S, RSM604877S, RSM612655S, RSM612656S, RSM612657S, RSM612659S, RSM621000S, RSM621003S, RSM621005S, RSM608749S, RSM608750S, RSM608751S, RSM608752S, RSM610434S, RSM610435S, RSM620999S, RSM621001S, RSM621004S, RSM617554S, RSM617555S, RSM617556S, RSM617558S, RSM617559S, RSM617557S, RSM613882S, RSM614841S, RSM615782S, RSM615936S, RSM616172S, RSM616444S, RSM619209S, RSM619289S, RSM619651S, RSM619896S, RSM620690S, RSM600889S, RSM604260S, RSM605557S, RSM606370S, RSM606396S, RSM607298S, RSM610073S, RSM610769S, RSM612584S, RSM618160S, RSM623166S, RSM600390S, RSM600757S, RSM600770S, RSM600846S, RSM600890S, RSM601127S, RSM601129S, RSM601133S, RSM604873S, RSM605085S, RSM605586S, RSM605863S |
|---|
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-1723-2023%22
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