Events

Recall of Oscor Electrode Cable

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Oscor 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
    21516
  • Event Initiated Date
    2017-06-09
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    In some cases during the use of some atar™ reusable extension cables, the cables was separating from the connector at the proximal end. the analysis of the returned devices revealed that the connector and wire separation was attributed to a fracture of the conductor cable most likely caused by extensive use of the reusable cables beyond the recommended maximum amount of 3 times. this event resulted in cable malfunction, causing interruption of the pacing system.
  • Action
    Product to be returned to supplier

Device

Oscor Electrode Cable

Manufacturer

Oscor Inc
  • Manufacturer Parent Company (2017)
    Oscor Inc.
  • Source
    NZMMDSA