Events

Recall of Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LivaNova Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01197-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01197-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
  • Model / Serial
    Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)Perceval Sutureless Heart Valve size SItem Number: ICV1208Reference: PVS21Perceval Sutureless Heart Valve size MItem Number: ICV1209Reference: PVS23Perceval Sutureless Heart Valve size LItem Number: ICV1210Reference: PVS25Perceval Sutureless Heart Valve size XLItem Number: ICV1211Reference: PVS27ARTG Number: 232485
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd