Events

Recall of Medtronic Clip Gun Scalp Clip 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-01527-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01527-1
  • 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 neurosurgery is initiating a recall of all affected model numbers and lot numbers of the clip gun scalp clip system.Testing performed by medtronic showed that the outer sterile pouch of the product did not meet standards for package integrity. specifically, the testing demonstrated that the outer pouch could be compromised and possibly go undetected by the user which could potentially lead to patient infections.
  • Action
    Medtronic are advising hospitals to cease use of affected product. Medtronic will arrange for retrieval of affected items.

Device

Medtronic Clip Gun Scalp Clip System
  • Model / Serial
    Medtronic Clip Gun Scalp Clip SystemGUN CG8900 RANEY CLIP KIT 1PKModel Number: CG8900 Item Number: 00643169109100Manufacture date: 26/05/2015 - 26/09/2017KIT CG8091 CLIP GUN 10 PKModel Number: CG8901Item Number: 20643169109111Manufacture date: 26/05/2015 - 02/06/2017ARTG Number: 98997
  • Product Classification
    Neurological Devices
  • 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