Sorin Group Italia S.r.l.: 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.

Agency Publication Date: September 18, 2020

Affected Products

Product: Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - 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.

Kit Lots: 2002200196, 2001300339, 2002130159

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.

Kit Lots: 2002200199, 2002200198, 2002130162, 2002130160, 2002060224 20013003412002130161

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.

Lot: 2002130166

Lot Numbers:

2002130166

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.

Kit Lots: 2002060216, 2002060218

Product: Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - 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.

Kit Lots: 2002060219, 2002060220

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86161

Status: Resolved

Manufacturer: Sorin Group Italia S.r.l.

Manufactured In: Italy

Units Affected: 5 products (77 kits; 94 kits; 102 kits; 225 kits; 498 units (component in kits 1-4))

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Sources: FDA iRES · Raw API Response

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