ELLIPSE DR — Class I medical device recall Z-2073-2019
Terminated recall by St Jude Medical Inc., reported 2019-08-14, distributed nationwide. Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs
| Recall number | Z-2073-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc., Sylmar, CA, United States |
| Recall initiated | 2019-06-20 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 21 |
| Serial numbers | 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516 |
| Model numbers | CD2377-36QC |
Product
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Reason for recall
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
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-2073-2019. 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.