Events

Recall of FlexStent Femoropopliteal Self-Exanding Stent System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Flexible Stenting Solutions Inc.

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
    14584
  • Event Initiated Date
    2013-05-02
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Endoventure Ltd, 2/1 Esmonde Road, Takapuna, Auckland
  • Reason
    Manufacturer has determined that during internal package integrity testing, following transportation simulation challenge, the sterile barrrier of the pouch (inner pouch) of some units of the flexistent could be compromised.And to a lesser degree, the outer pouch., to date no complaints associated with this potential mode of failure have been reported., in the event a hole or a tear in the clear film side of the pouch of the affected product is present and both pouches are affected, loss of the sterile barrier could occur, leading to use of a non-sterile device in the procedure.
  • Action
    Product to be returned to supplier

Device

FlexStent Femoropopliteal Self-Exanding Stent System

Manufacturer

Flexible Stenting Solutions Inc