Events

Recall of Abbott Hi-Torque Connect Peripheral Guide Wire

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Lake Region Medical 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
    15736
  • Event Initiated Date
    2013-11-27
  • 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: Abbott Vascular Division of Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mount Wellington, Auckland 1060
  • Reason
    Abbott vascular has initiated this recall due to a small number of devices exhibiting partial delamination of the ptfe coating. to date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%. while there have been no long term or irreversible patient effects reported, potential risks associated with delamination of the coating include embolism, thrombus and occlusion in the peripheral vessels.
  • Action
    Product to be returned to supplier

Device

Abbott Hi-Torque Connect Peripheral Guide Wire
  • Model / Serial
    Model: Part Numbers: 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595, Affected: All lot numbers
  • Manufacturer
    Lake Region Medical Ltd

Manufacturer

Lake Region Medical Ltd