Events

Safety Alert for 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device

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

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
    2013-08-01
  • Event Date Posted
    2013-08-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130801.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 4mm x 15mm small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation device, and 4mm x 15mm flextome cutting balloon (monorail and over-the-wire) microsurgical dilatation device medical device manufacturer, boston scientific, has issued a field safety notice concerning 4mm x 15mm small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation device, and 4mm x 15mm flextome cutting balloon (monorail and over-the-wire) microsurgical dilatation device. the expiration date range from 16 november 2015 to 03 june 2016. users may experience significant difficulty or inability to remove protector cap from device which may result in damage to the device. boston scientific has received 45 complaints related to this issue from april 2013 to current date, none of which have resulted in patient injury and no additional risk to the patient is expected to occur as a result of this issue. according to the manufacturer, further distribution or use of affected products should cease immediately. users should segregate and return affected products to boston scientific. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 august 2013.

Device

4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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