Perceval Sutureless Aortic Heart Valve size S — Class II medical device recall Z-0716-2017
Terminated recall by Sorin Group USA, Inc., reported 2016-12-14, distributed nationwide. Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to update
| Recall number | Z-0716-2017 |
|---|---|
| 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 | 2016-10-31 |
| Classified | 2016-12-07 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IT, JO, KR, KW, LU, MT, MX, MY, NO, NZ, PA, PL, PT, RO, RS, SA, SG, SI, SK, TH, TR, TW, UY |
| Quantity | 845 units |
| Model numbers | ICV1208, ICV1209, ICV1210, ICV1211, PVS21, PVS23, PVS25, PVS27 |
Product
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Reason for recall
Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
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-0716-2017. 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.