CAUSALITY COLLAPSER CODE

Please ensure that this notice is communicated to all personnel within your organization who Coordinating and providing information to the user on product replacement.Transmission of this Communication Notification of the potentially affected devices removal via letter to inform users of the issueДЄnd advise them not to use and quarantine the potentially affected devices immediately Дў. Your LivaNova Representative will contact you to coordinate replacement of the potentiallyДefective device(s) if they have not already been used.ДЎ. Please complete and return the Attachment 1 by e-mail to initiate the removal/replacement process of the Perceval single-use accessory kit(s). Used and should be quarantined, pending return of the devices to LivaNova ДЈ. All potentially affected devices listed in Attachment 1 and still in inventory should not be Using the list provided in Attachment 1, please check your inventory for potentially affectedДў. Please ensure timely execution of the following actions:ДЎ. Use accessory kit lots in your inventory.

LivaNova is coordinating the removal and replacement of all potentially affected Perceval single The issue potentially affects kits assembled (Perceval S and Perceval PLUS) while using specific lots of Perceval O It could be impossible to collapse Perceval Sutureless heart valves Letter titled, Urgent Medial Device Removal, Perceval single-use accessory kit models assembly error, HV-SAL-2020-1, dated Jwas sent to consignees via 1st class mail (certified return receipt) on July 29th, 2020 The issue is relevant to specific lots of Dual Collapser size S/M. 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 LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure.

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.

CAUSALITY COLLAPSER CODE

Heart-valve, non-allograft tissue - Product Code LWR Class 2 Device Recall PERCEVAL SUTURELESS HEART VALVE

Causality collapser