Events

Recall of Acclarent Inspira Air Balloon Dilation System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Acclarent 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
    15287
  • Event Initiated Date
    2013-09-11
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Reports of difficulty deflating the balloon during a procedure have been received. in each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. the potential for this phenomenon to occur exists in all lots and all sizes of the inspira air balloon dilation system.
  • Action
    Instructions for use to be updated

Device

Acclarent Inspira Air Balloon Dilation System
  • Model / Serial
    Model: Product Codes: BC0524A, BC0524AZ, BC0724A, BC0724AZ, BC1040A, BC1040AZ, BC1440A, BC1440AZ, Affected: All lots
  • Manufacturer
    Acclarent Inc

Manufacturer

Acclarent Inc