FDA Device recall Z-1486-2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D…
- 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 with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D… 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-1486-2022 |
| 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 with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
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: DTPA2D4: GTIN 00763000178130, Serial Numbers: RTG600136S, RTG600270S, RTG601323S, RTG601338S, RT…a. Model Numbers: DTPA2D4: GTIN 00763000178130, Serial Numbers: RTG600136S, RTG600270S, RTG601323S, RTG601338S, RTG601367S, RTG601433S, RTG601484S, RTG601489S, RTG601575S, RTG601583S, RTG601595S, RTG601632S, RTG601643S, RTG601653S, RTG601657S, RTG601669S, RTG601775S, RTG601790S, RTG601802S, RTG601805S, RTG601820S, RTG601847S, RTG601892S, RTG601904S, RTG601968S, RTG602017S, RTG602019S, RTG602125S, RTG602147S, RTG602179S, RTG602182S, RTG602191S, RTG602207S, RTG602209S, RTG602221S, RTG602226S, RTG602238S, RTG602239S, RTG602360S, RTG602439S, RTG602477S, RTG602480S, RTG602490S, RTG602506S, RTG602512S, RTG602515S, RTG602516S, RTG602524S, RTG602550S, RTG602580S, RTG602584S; GTIN 00763000178154, Serial Numbers: RTG600028S, RTG600029S, RTG600030S, RTG600033S, RTG600036S, RTG600037S, RTG600040S, RTG600048S, RTG600049S, RTG600054S, RTG600055S, RTG600056S, RTG600059S, RTG600060S, RTG600061S, RTG600062S, RTG600063S, RTG600064S, RTG600065S, RTG600066S, RTG600067S, RTG600068S, RTG600069S, RTG |
|---|
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-1486-2022%22
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