Events

Recall of Versate Monofilament Mesh, 50x50 cm

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-2018-RN-00191-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00191-1
  • 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 has been made aware of patient reports of abdominal hernia recurrence following hernia repair using versatex monofilament mesh 50 x 50 cm. the risk is highest in patients who have comorbidities. the majority of these patients have been confirmed to have undergone the transversus abdominis muscle release (tar) procedure.
  • Action
    Medtronic is adding the following statement to the Versatex monofilament mesh Instructions for Use so that surgeons are aware of the risks involved in using Versatex monofilament mesh 50x50 cm in TAR procedures: "In case of large abdominal wall defects, use of Versatex monofilament mesh in posterior component separation techniques with transversus abdominis muscle release may lead to a higher risk of hernia recurrence. Versatex monofilament mesh is not recommended for posterior component separation techniques with transversus abdominis muscle release when the mesh is used as a bridging material for the lateral relaxing incisions."

Device

Versate Monofilament Mesh, 50x50 cm
  • Model / Serial
    Versate Monofilament Mesh, 50x50 cmItem Code: VTX5050MARTG Number: 237409(Medtronic Australasia - Abdominal hernia surgical mesh, synthetic polymer)
  • 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