Events

Recall of EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien 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-2014-RN-00431-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00431-1
  • 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
    Covidien is conducting a recall of two production lots of the evercross 0.035 pta balloon catheter because of a product labelling error. based on customer reports and covidien's internal investigation, it has been identified that there is a discrepancy in the pta balloon length and the delivery catheter length printed on the product labelling.
  • Action
    Customers are advised to immediately discontinue the use of the affected device and segregate this product from other inventory for returning to Covidien

Device

EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)
  • Model / Serial
    EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)Product code: AB35W06120135 and AB35W06040080Lot numbers: 9855406 and 9855291ARTG number: 172929
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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