Perceval Dual Collapser — Class II medical device recall Z-2988-2020
Terminated recall by Sorin Group Italia S.r.l., reported 2020-09-30, distributed nationwide. LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dua
| Recall number | Z-2988-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group Italia S.r.l., Saluggia, N/A, Italy |
| Recall initiated | 2020-07-29 |
| Classified | 2020-09-18 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2021-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, DE, ES, FI, FR, GB, GR, HR, HU, IL, IR, IT, JP, KW, MT, OM, PL, RO, RS, RU, SE, SG, SI, TH, TW, ZA |
| UPC / GTIN / UDI-DI | 08022057014832 |
| Lot numbers | 2002130166 |
| Model numbers | ICV1235 |
Product
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
Reason for recall
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
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-2988-2020. 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.