Events

Safety Alert for RIGIFLEX II Single Use Achalasia Balloon Dilator

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
    2013-05-31
  • Event Date Posted
    2013-05-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130531b.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 rigiflex ii single use achalasia balloon dilator medical device manufacturer, boston scientific, has issued a field safety notice concerning rigiflex ii single use achalasia balloon dilator with: material no.: m00554510 catalogue no.: 5451 lot/batch no.: 091541 expiration date: 2013-12 boston scientific has become aware that the pouch label expiration date on a single lot/batch of rigiflex ii single use achalasia balloon dilators is labeled with the incorrect expiration date, 0213-12. boston scientific has confirmed that the correct expiration date is 2013-12 (in the year-month format, yyyy-mm). the product is not expired and there is no patient risk related to the labeling issue if the product is used prior to 2013-12. the manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product. according to the local supplier, affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 may 2013.

Device

RIGIFLEX II Single Use Achalasia Balloon Dilator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific RIGIFLEX II Single Use Achalasia Balloon Dilator
  • 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