Events

Recall of PIPELINE EMBOLIZATION DEVICE (25-35MM)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA 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
    41765
  • Event Risk Class
    I
  • Event Initiated Date
    2016-10-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Medtronic has identified the potential for an issue with a specific set of lot numbers where the ptfe (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. delamination and detachment of the ptfe coating material may lead to ptfe coating in the blood stream. ptfe in the blood stream based on its specific size and quantity may be safe or could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial edema peripheral edema incomplete treatment infection local inflammatory response systemic inflammatory response ischemic stroke lysis/necrosis neurological deficit organ impairment shock space occupying lesion thrombosis and hemorrhage. through september 27 2016 medtronic has received a total of five (5) reports for the products that are potentially affected by this issue. medtronic has received no reports of serious injuries or patient death as a result of this issue.

Device

PIPELINE EMBOLIZATION DEVICE (25-35MM)
  • Model / Serial
    Model Catalog: FA-71500-25 (Lot serial: A090167); Model Catalog: FA-71400-25 (Lot serial: A090167); Model Catalog: FA-71450-25 (Lot serial: A090167); Model Catalog: FA-71475-25 (Lot serial: A090167); Model Catalog: FA-71425-25 (Lot serial: A090167); Model Catalog: FA-71375-25 (Lot serial: A090167); Model Catalog: 103-0602-300 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 103-0601-300 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 105-5055 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-40 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-50 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-30 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-20 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-71500-25 (Lot serial: A090209); Model Catalog: FA-71400-25 (Lot serial: A090209); Model Catalog: FA-71450-25 (Lot serial: A090209); Model Catalog: FA-71475-25 (Lot serial: A090209); Model Catalog: FA-71425-25
  • Product Classification
    Neurological Devices
  • Product Description
    PIPELINE EMBOLIZATION DEVICE (25-35MM);X-CELERATOR EXCHANGE HYDROPHILIC GUIDEWIRE - SS;MARATHON FLOW DIRECTED MICRO CATHETER;ALLIGATOR RETRIEVAL DEVICE;ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • 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
    HC