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 ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED).

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
    40619
  • Event Risk Class
    I
  • Event Initiated Date
    2009-02-10
  • 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
    Blue connector for 40cc iab not properly recognized by iab pump system.Fault in connector of pump tubing assembly may result in volume setting on pump defaulting to 2.5 or 5cc rather than 3040 or 50cc.

Device

ULTRA 8 INTRA-AORTIC BALLOON - LIGHTWAVE SENSOR
  • Model / Serial
    Model Catalog: IAB-05830-LWS (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-06840-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-05830-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-05840-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-05840-LWS (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-04840-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-S730C (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-04830-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-R950-U (Lot serial: >10 #scontact manufacturer); Model Catalog: IAK-02691 (Lot serial: >10 #scontact manufacturer); Model Catalog: IAB-S840C (Lot serial: >10 #scontact manufacturer); Model Catalog: IAK-02692 (Lot serial: >10 #scontact manufacturer)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    ULTRA 8 IAB - LIGHTWAVE SENSOR
  • Manufacturer
    ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)

Manufacturer

ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)