Events

Recall of ULTRA 8 INTRA-AORTIC BALLOON - LIGHTWAVE SENSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL CANADA 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
    74003
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-26
  • 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
    There is an increase in "stuck in sheath" reports involving the use of the superarrowflex (wire-reinforced) sheath with the iab-058xx catheter series. when the iab becomes stuck in the sheath the user is unable to move the iab catheter forward or backward potentially causing a delay in this critical therapy.

Device

ULTRA 8 INTRA-AORTIC BALLOON - LIGHTWAVE SENSOR
  • Model / Serial
    Model Catalog: IAB-05830-LWS (Lot serial: All lots); Model Catalog: IAB-05840-LWS (Lot serial: All lots); Model Catalog: IAK-05845 (Lot serial: All lots); Model Catalog: IAB-05830-U (Lot serial: All lots); Model Catalog: IAB-05840-U (Lot serial: All lots)
  • Product Description
    ULTRA 8 INTRA-AORTIC BALLOON SENSOR
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.