Events

Recall of LeMaitre_14339_IIa_Valvulotome

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by LeMaitre Vascular 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
    21089
  • Event Initiated Date
    2017-02-09
  • 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: Clinical & Regulatory Services Limited, 50B Puketapu Road, Taradale, Napier 4112
  • Reason
    There have been issues of hoops failing to close when the device was actuated. in some cases, this issue has been discovered in-use and has led to vessel damage. if the blades are stuck in the open position, the device must be removed in the open state. the removal of the device without sheathing may cause damage to the vein either during use or when the blades pass the opening of the vessel.
  • Action
    Product to be returned to supplier

Device

LeMaitre_14339_IIa_Valvulotome

Manufacturer

LeMaitre Vascular Inc