FDA Device recall Z-1818-2023
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1 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-1818-2023 |
| 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 VR MRI IS1 DF1, Model Number DVPA2D1; 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 00763000178451, Lot Serial Numbers: RSC601940S, RSC601072S, RSC601241S, RSC600327S, RSC601396S, RSC602028S, RSC60…GTIN 00763000178451, Lot Serial Numbers: RSC601940S, RSC601072S, RSC601241S, RSC600327S, RSC601396S, RSC602028S, RSC602030S, RSC602031S, RSC602036S, RSC600018S, RSC602529S, RSC602530S, RSC602531S, RSC602532S, RSC600347S, RSC600391S, RSC600419S, RSC601490S, RSC602703S, RSC600337S, RSC600420S, RSC600421S, RSC600422S, RSC600423S, RSC600501S, RSC601410S, RSC601433S, RSC602269S, RSC601444S, RSC601446S, RSC602764S, RSC602765S, RSC600131S, RSC600281S, RSC600298S, RSC601388S, RSC602497S, RSC600174S, RSC602387S, RSC601415S, RSC602106S, RSC600225S, RSC600240S, RSC601647S, RSC602710S, RSC601960S, RSC601961S, RSC602209S, RSC602257S, RSC602306S, RSC602379S, RSC602473S, RSC600293S, RSC600299S, RSC600328S, RSC601071S, RSC601345S, RSC601443S, RSC601450S, RSC601632S, RSC601887S, RSC602213S, RSC602144S, RSC602234S, RSC601419S, RSC602168S, RSC600147S, RSC600417S, RSC601631S, RSC600275S, RSC601999S, RSC602394S, RSC602701S, RSC602752S, RSC602620S, RSC600443S, RSC602061S, RSC602064S, RSC602068S, RSC602072S |
|---|
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-1818-2023%22
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