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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01197-1
Product Name/Description	Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve) Perceval Sutureless Heart Valve size S Item Number: ICV1208 Reference: PVS21 Perceval Sutureless Heart Valve size M Item Number: ICV1209 Reference: PVS23 Perceval Sutureless Heart Valve size L Item Number: ICV1210 Reference: PVS25 Perceval Sutureless Heart Valve size XL Item Number: ICV1211 Reference: PVS27 ARTG Number: 232485
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	18/10/2016
Responsible Entity	LivaNova Australia Pty Ltd
Reason/Issue	Following some cases (55 out of 16048 devices sold) of intra/peri-operative central leak, LivaNova is providing clarifications about the implant techniques for the Perceval Sutureless Aortic Heart Valve and bringing to the attention of users some steps that may influence procedural success and potential complications. This information is being provided in the document IM-00763 Perceval Implant Key Points and will subsequently be integrated into upcoming revisions of the Instructions for Use (IFU) and the InService Guide training material.
Recall Action	Recall for Product Correction
Recall Action Instructions	LivaNova is providing users with information that clarifies implantation steps, in the form of the document IM-00763 Perceval Implant Key Points. Upcoming revisions of the IFU and InService Guide will incorporate this information. This action has been closed-out on 16/02/2017.
Contact Information	1800 452 650 - LivaNova Australia