Events

Recall of Biosensors Biomatrix Flex Drug Eluting Stent

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Biosensors Europe SA.

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
    19857
  • Event Initiated Date
    2016-03-07
  • 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
    Manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, manufacturer concluded that the compromised balloon performance was caused by certain characteristics in the manufacturing process. biosensors positively identified production lots manufactured between october to december 2015 that could have been similarly affected., the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient's state of health during pci., patients who have already been implanted with an affected device are not impacted by this field safety corrective action. no field complaint or patient injury has been reported associated with the compromised balloon performance.
  • Action
    Product to be returned to supplier

Device

Biosensors Biomatrix Flex Drug Eluting Stent
  • Model / Serial
    Model: BMX-3511, BMX-3518, BMX-3524, BMX-4018, Affected: Batches : K15100000 K15100011 K15110086 K15110054 K15100017 K1510017 K15110058 W15110058
  • Manufacturer
    Biosensors Europe SA

Manufacturer

Biosensors Europe SA