Isoline Implantable Defibrillation Lead — Class II medical device recall Z-0928-2013
Terminated recall by Sorin Group USA, Inc., reported 2013-03-20, distributed nationwide. Isoline defibrillation leads distributed may have internal insulation breach.
| Recall number | Z-0928-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2013-01-28 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2015-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CZ, DE, DK, EG, ES, FR, GB, GR, HK, IE, IL, IN, IR, IT, JP, KW, LB, MA, NL, PT, RU, SA, SE, SI, TN, UA, UY |
| Quantity | 1,376 isoline |
| Model numbers | 2CR5, 2CR6, 2CT6 |
Product
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Reason for recall
Isoline defibrillation leads distributed may have internal insulation breach.
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-0928-2013. 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.