Events

Recall of GastriSail Gastric Positioning System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia 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-2017-RN-01227-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01227-1
  • 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
    Medtronic is recalling specific production lots of its gastrisail gastric positioning system device. this recall is being conducted following customer reports of oesophageal or gastric perforations during bariatric procedures where the gastrisai gastric positioning system was used. eighteen reports, representing 0.08% of devices, were received regarding this issue; many of these perforations were identified post-operatively. according to complaints, the part of the device causing perforation may be the distal tip during device insertion or when meeting resistance as it is advanced. some complaints also referenced tissue trauma or perforation thought to be caused by inability to fully retract the sail, leading to kinking of the sail and risk to tissue.
  • Action
    Medtronic requests that users quarantine and return any unused products of the items. All unused products from the affected item code and lots should be returned to Medtronic.

Device

GastriSail Gastric Positioning System
  • Model / Serial
    GastriSail Gastric Positioning SystemItem Code: GPS36All Lot NumbersExpiry date: September 2017 to May 2018ARTG Number: 246455
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA