Events

Recall of ATAR DISPOSABLE EXTENSION CABLES

According to Health Canada (via FOI), this recall involved a device in Canada 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
    45613
  • Event Risk Class
    I
  • Event Initiated Date
    2017-07-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    During the use of some atar extension cables the cable was seperating from the connector at the proximal end. analysis revealed that the connector and wire separation was attributed to a fracture of the conductor cable malfunction causing interruption of the pacing system. the cause for the failure are attributed to a combination of manufacturing process and field misuse of the cables.

Device

ATAR DISPOSABLE EXTENSION CABLES
  • Model / Serial
    Model Catalog: ATAR D-R 1 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-MDT (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-V (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-R D2P (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-A (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-R (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-MDTR (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-MDT2 (Lot serial: > THAN 10 CONTACT MFR)
  • Product Classification
    Physical Medicine Devices
  • Product Description
    ATAR DISPOSABLE EXTENSION CABLES
  • Manufacturer
    OSCOR INC.

Manufacturer

OSCOR INC.
  • Manufacturer Address
    PALM HARBOR
  • Manufacturer Parent Company (2017)
    Oscor Inc.
  • Source
    HC