Events

Recall of Medtronic Navigation Bags & Drapes

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

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
    16614
  • Event Initiated Date
    2014-05-06
  • 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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Reason
    A review of the medtronic internal returned goods procedures showed that there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. this review identfied the sterile part numbers were processed through the returned goods procedures. a risk analysis was subsequently performed showing that, since there have been no complaints related to sterilisation/package damage there was no change in the likeihood of this scenario leading to harm. although there have been no reports of issues related to package sterile barrier damage, manufacturer has elected to issue this safety notice to address this possibility.
  • Action
    Product to be returned to supplier

Device

Medtronic Navigation Bags & Drapes
  • Model / Serial
    Model: Part Number: 9732315 & 9732722, Affected: Lot Number: 5246110712, 5316560113 & 6 lots respectively
  • Manufacturer
    Medtronic Xomed

Manufacturer

Medtronic Xomed
  • 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
    NZMMDSA