Ellipse ICD — Class II medical device recall Z-1632-2016
Terminated recall by St Jude Medical Inc., reported 2016-05-18, distributed nationwide. St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential in
| Recall number | Z-1632-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc., Sylmar, CA, United States |
| Recall initiated | 2016-03-31 |
| Classified | 2016-05-09 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2016-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, ES, FI, FR, GB, GR, IE, IL, IT, JP, KW, LB, NL, PL, RO, SK, VN |
| Quantity | 127 units |
| Serial numbers | 7263877, 7263892, 7263900, 7263904, 7263916, 7264199, 7264214, 7264398, 7265399, 7265400, 7265401, 7265581 |
| Model numbers | CD1411-36C, CD1411-36Q, CD2411-36C, CD2411-36Q |
Product
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Reason for recall
St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
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-1632-2016. 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.