Events

Safety Alert for Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Arrow International.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-02-26
  • Event Date Posted
    2016-02-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160226.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: arrow intra-aortic balloon catheter kits and percutaneous insertion kits the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning arrow intra-aortic balloon catheter kits and percutaneous insertion kits manufactured by arrow international, inc. the arrow intra-aortic balloon catheter kits 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 issue pertains to the sheath introducer in the insertion kit only. the other components of the kits are unaffected. 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 intra-aortic balloon therapy can occur. the manufacturer is advising customers to immediately quarantine all affected kits. the manufacturer will deliver replacement kits to the affected customers before the recovery of the affected kit. the manufacturer advises users that in the case of an emergency situation before the replacement kit can be delivered, the arrow intra-aortic balloon catheter can be inserted through the following alternative 8 fr. sheaths: -st jude medical diag maximum -terumo pinnacle -cordis avanti for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00204-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 26 february 2016.

Device

Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: ARROW Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
  • Manufacturer
    Arrow International

Manufacturer

Arrow International