Events

Recall of SPYSCOPE DS ACCESS AND DELIVERY CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOSTON SCIENTIFIC 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
    100652
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-15
  • 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
    Potential for these devices to not perform as intended. an internal investigation found that the working channel sleeve may not be adequately bonded inside of these devices. this may result in the working channel sleeve protruding from the camera cap located at the distal tip of the catheter. the most common injury reported has been minor tissue damage caused by the protruding working channel sleeve scraping along the duct walls during the procedure .

Device

SPYSCOPE DS ACCESS AND DELIVERY CATHETER
  • Model / Serial
    Model Catalog: M00546600 (Lot serial: 21169977); Model Catalog: M00546600 (Lot serial: 21159396); Model Catalog: M00546600 (Lot serial: 21332229); Model Catalog: M00546600 (Lot serial: 21212151); Model Catalog: M00546600 (Lot serial: 21264826); Model Catalog: M00546600 (Lot serial: 21237929)
  • Product Description
    SPYSCOPE DS ACCESS AND DELIVERY CATHETER
  • Manufacturer
    BOSTON SCIENTIFIC LTD.

Manufacturer

BOSTON SCIENTIFIC LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HC