Events

Safety Alert for RunWay Guide Catheter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-03-07
  • Event Date Posted
    2014-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140307b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific runway guide catheter medical device manufacturer, boston scientific corporation, has issued a medical device safety alert concerning runway guide catheter with catalogue no.: 38969-664 and lot no.: 2013040058. the expiry date of the affected product is april 2016. the manufacturer is initiating a product recall as the sterile pouch of the affected devices may not be completely sealed and sterility may be compromised. to date, the manufacturer has received one complaint for this issue. the most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy. according to the local supplier, the affected lot was not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

RunWay Guide Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific RunWay Guide Catheter
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 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
    DH