Recall Z-2984-2020— Sorin Group Italia S.r.l.
Class II · Terminated
Class II FDA medical device recall by Sorin Group Italia S.r.l., initiated 2020-07-29, terminated 2021-05-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - 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..
- Recalling firm
- Sorin Group Italia S.r.l.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-29
- Terminated
- 2021-05-17
- Firm location
- Saluggia, N/A, Italy
Product description
Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.