Events

Recall of ULTRAFLEX INTRA-AORTIC BALLOON

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
    72438
  • Event Risk Class
    I
  • Event Initiated Date
    2016-02-17
  • 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
    Arrow is recalling these products due to the possibility that the sheath body may become separated from the sheath hub. if the separation occurs there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention it may result in loss of significant blood volume or exsanguination. in addition delay of treatment interruption of treatment or loss of iab therapy can occur.

Device

ULTRAFLEX INTRA-AORTIC BALLOON
  • Model / Serial
    Model Catalog: IAB-06840-U (Lot serial: > 100 numbers contact mfg); Model Catalog: IAB-05830-LWS (Lot serial: > 100 numbers contact mfg); Model Catalog: IAB-05840-LWS (Lot serial: > 100 numbers contact mfg); Model Catalog: IAB-06830-U (Lot serial: > 100 numbers contact mfg); Model Catalog: IAB-05830-U (Lot serial: > 10 numbers contact mfg); Model Catalog: IAB-05840-U (Lot serial: > 10 numbers contact mfg); Model Catalog: IAK-06845 (Lot serial: > 10 numbers contact mfg)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    ULTRAFLEX INTRA-AORTIC BALLOON;ULTRA 8 INTRA-AORTIC BALLOON - LIGHTWAVE SENSOR;ULTRA IAB CATHETER KIT;PERCUTANEOUS INSERTION KIT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.