FDA Device recall Z-1721-2023
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1
- 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 DF1, Model Number DDPA2D1 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-1721-2023 |
| 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 DF1, Model Number DDPA2D1; 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 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL60…GTIN 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL602893S, RSL602901S, RSL602941S, RSL602955S, RSL602420S, RSL602899S, RSL601490S, RSL602690S, RSL600167S, RSL600499S, RSL600561S, RSL600563S, RSL600564S, RSL600565S, RSL601867S, RSL601868S, RSL601870S, RSL601966S, RSL603729S, RSL601838S, RSL602889S, RSL600163S, RSL602444S, RSL602823S, RSL602826S, RSL603092S, RSL603105S, RSL603233S, RSL603237S, RSL603565S, RSL600206S, RSL600230S, RSL600231S, RSL601723S, RSL601789S, RSL601878S, RSL602705S, RSL602854S, RSL602828S, RSL602933S, RSL603236S, RSL601484S, RSL601988S, RSL603618S, RSL602324S, RSL602979S, RSL603759S, RSL600237S, RSL601990S, RSL600172S, RSL602465S, RSL602466S, RSL602467S, RSL602468S, RSL602469S, RSL602470S, RSL602471S, RSL602472S, RSL602892S, RSL603257S, RSL603262S, RSL603263S, RSL603264S, RSL601873S, RSL601874S, RSL601875S, RSL601876S, RSL601887S, RSL601895S, RSL602043S, RSL602044S, RSL602045S, RSL602046S, RSL602047S |
|---|
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-1721-2023%22
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