Events

Recall of ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical Australia Pty Ltd.

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
    RC-2016-RN-00204-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00204-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The arrow intra-aortic balloon catheter and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the manufacturer has advised there is the possibility that the percutaneous sheath introducer 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.
  • Action
    The sponsor is advising customers to immediately quarantine all affected kits. The sponsor will deliver replacement kits to the affected customers before the recovery of the affected kit. In the case of an emergency situation before the replacement kit can be delivered, the sponsor is advising that the Arrow IntraAortic Balloon Catheter can be inserted through the following alternative 8 Fr. sheaths: -St Jude Medical Diag Maximum -Terumo Pinnacle -Cordis Avanti . This action has been closed-out on 23/05/2017.

Device

ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits
  • Model / Serial
    ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion KitsProduct Codes : IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-06830-U, IAB-06840-U and IAK-06845Multiple Batch Numbers affectedARTG Numbers: 101617, 106866 and 107249
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd