Events

Recall of Arrow Berman Angiographic Balloon Catheters

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
    14113
  • Event Initiated Date
    2013-01-22
  • 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 manufacturer advises that the labelling for the product numbers listed above formerly referenced renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. arrow is in the process of updating the labelling and instructions for use for these products. in the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current ifu.
  • Action
    Manufacturer to issue advice regarding use

Device

Arrow Berman Angiographic Balloon Catheters
  • Model / Serial
    Model: Part numbers: AI-07130, AI-07130J, AI-07131, AI-07132, AI-07133, AI-07134, AI-07135, AI-07136, AI-07137, AI-07138, Affected: All lots
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc