FDA Device recall Z-1485-2022
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4
- FDA Device
- Class I
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class I recall of Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1485-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-22 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
Reason
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Identifiers
| code_info | a. Model Numbers: DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600237S, RSC600256S, RSC600277S, RSC600327S, RS…a. Model Numbers: DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600237S, RSC600256S, RSC600277S, RSC600327S, RSC600419S, RSC601038S, RSC601061S, RSC601065S, RSC601084S, RSC601126S, RSC601134S, RSC601138S, RSC601158S, RSC601159S, RSC601175S, RSC601193S, RSC601209S, RSC601210S, RSC601213S, RSC601214S, RSC601217S, RSC601226S, RSC601242S, RSC601244S, RSC601249S, RSC601313S, RSC601314S, RSC601315S, RSC601317S, RSC601323S, RSC601330S, RSC601332S, RSC601337S, RSC601341S, RSC601342S, RSC601346S, RSC601349S, RSC601354S, RSC601358S, RSC601370S, RSC601372S, RSC601377S, RSC601379S, RSC601397S, RSC601402S, RSC601411S, RSC601420S, RSC601422S, RSC601438S, RSC601441S, RSC601446S, RSC601453S, RSC601467S, RSC601473S, RSC601476S, RSC601486S, RSC601493S, RSC601494S, RSC601500S, RSC601506S, RSC601510S, RSC601511S, RSC601516S, RSC601520S, RSC601525S, RSC601526S, RSC601532S, RSC601539S, RSC601542S, RSC601581S, RSC601622S, RSC601627S, RSC601628S, RSC601631S, RSC601635S, RSC601636S, RSC601644S, RSC6016 |
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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-1485-2022%22
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