Cobalt Implantable Cardioverter Defibrillators with Cardiac… — Class I medical device recall Z-1486-2022
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2022-08-17. There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy f
| Recall number | Z-1486-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2022-06-22 |
| Classified | 2022-08-08 |
| Reported by FDA | 2022-08-17 |
| Quantity | 8,429 units |
| UPC / GTIN / UDI-DI | 00763000178093, 00763000178109, 00763000178116, 00763000178123, 00763000178130, 00763000178147, 00763000178154, 00763000178161, 00763000402204, 00763000402211, 00763000402228, 00763000402235 |
| Serial numbers | 8319S, DTPA2D1, DTPA2Q1, RTC60, RTC600048S, RTC600050S, RTC600053S, RTC600055S, RTC600056S, RTC600057S, RTC600058S, RTC600059S, RTC600060S, RTC600061S, RTC600062S, RTC600063S, RTC600064S, RTC600065S, RTC600066S, RTC600067S, RTC600068S, RTC600069S, RTC600070S, RTC600071S, RTC600072S and 475 more |
| Model numbers | DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ |
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 for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1486-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.