Optisure Dual Coil Defibrillation Leads — Class I medical device recall Z-0660-2016
Terminated recall by St Jude Medical Cardiac Rhythm Management Division, reported 2016-01-27, distributed nationwide. Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC
| Recall number | Z-0660-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Cardiac Rhythm Management Division, Sylmar, CA, United States |
| Recall initiated | 2015-11-03 |
| Classified | 2016-01-20 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2019-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, FR, GB, IN, IT, JP, LU, NL, SA, SE |
| Model numbers | LDA220, LDA220Q, LDA230Q, LDP220Q |
Product
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Reason for recall
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
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-0660-2016. 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.