Events

Recall of AngioDynamics Morpheus Smart PICC CT (Central venous catheters)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical Specialties Australia Pty Ltd.

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
    RC-2015-RN-00263-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00263-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Angiodynamics, the manufacturer of morpheus smart picc ct kits is conducting a medical device recall on specific kit / lot numbers of power injectable picc catheters. based on a review of complaints, angiodynamics has determined that the power injectable picc catheters contained in these kits exhibit a higher than anticipated rate of extension tube fracture or leakage. use of the picc catheters that are subject to this recall may have an increased incidence of extension tube fractures or leakage which would require replacement of the picc catheter.
  • Action
    Customers are advised to segregate affected stock to a secure location for return to the Medical Specialties Australia. This action has been closed-out on 1/06/2016.

Device

AngioDynamics Morpheus Smart PICC CT (Central venous catheters)
  • Model / Serial
    AngioDynamics Morpheus Smart PICC CT (Central venous catheters)Catalogue number:12102602 Lot number: 583841 Catalogue number: 12102605Lot number: 588129Catalogue number:12102802Lot number: 601006 Catalogue number:12102813Lot number: 603510ARTG number: 204787
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA