FDA Device recall Z-2987-2020
Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is…
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is… by Sorin Group Italia S R L, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2987-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-29 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Sorin Group Italia S R L |
| Distribution | US |
Product
Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - 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
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.
Identifiers
| code_info | Kit Lots: 2002200199, 2002200198, 2002130162, 2002130160, 2002060224 20013003412002130161 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2987-2020%22
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