Events

Recall of Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Arrow International 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
    19818
  • Event Initiated Date
    2016-03-04
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    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., this notice is required following notification by the manufacturer of 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
    Product to be returned to supplier

Device

Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits
  • Model / Serial
    Model: IAB-05830-LWS IAB-05830-U IAB-05840-LWS IAB-05840-U IAB-06830-U IAB-06840-U and IAK-06845 (Percutaneous Insertion Kit), Affected: Multiple
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc