Events

Recall of Percuvance Percutaneous Surgical System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical 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-2017-RN-01400-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01400-1
  • 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
    Teleflex has identified that the percuvance percutanous surgical system jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. if breakage occurs during a procedure, additional operating time or enlargement of the incision may be required to retrieve the fragment from the patient. if the fragment cannot be retrieved easily, additional complications could occur. teleflex has not received any reports of patient injuries or deaths relating to the recalled products.
  • Action
    Teleflex is advising users to quarantine any remaining units of the affected stock for credit.

Device

Percuvance Percutaneous Surgical System

Manufacturer

Teleflex Medical Australia Pty Ltd