Cobalt Implantable Cardioverter Defibrillators with Cardiac… — Class I medical device recall Z-1488-2022
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-1488-2022 |
|---|---|
| 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 | 1,408 units |
| UPC / GTIN / UDI-DI | 00763000178178, 00763000178185, 00763000178192, 00763000178208, 00763000178215, 00763000178222, 00763000178239, 00763000178246 |
| Serial numbers | DTPB2D1, DTPB2Q1, RTK600014S, RTK600015S, RTK600023S, RTK600024S, RTK600026S, RTK600027S, RTK600028S, RTK600029S, RTK600030S, RTK600031S, RTK600032S, RTK600033S, RTK600034S, RTK600035S, RTK600037S, RTK600038S, RTK600039S, RTK600041S, RTK600042S, RTK600043S, RTK600044S, RTK600045S, RTK600048S and 475 more |
| Model numbers | DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ |
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
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-1488-2022. 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.