Events

Safety Alert for Extractor Pro XL Retrieval Balloon Catheter

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
    2013-12-23
  • Event Date Posted
    2013-12-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131223a.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 extractor pro xl retrieval balloon catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its extractor pro xl retrieval balloon catheter. the material numbers (upn) of the affected products with expiration date of 31 july 2015 are as follows: m00547100 (with catalogue no.: 4710 and lot no.: 16231178) m00547110 (with catalogue no.: 4711 and lot no.: 16231174) m00547140 (with catalogue no.: 4714 and lot no.: 16230354) the manufacturer is initiating this medical device recall for three lots of the extractor pro xl retrieval balloon catheter device. the manufacturer has become aware that these three lots may be labeled with an incorrect balloon size and/ or skive injection location. if the extractor device is smaller than the included syringe, balloon burst may occur and air may be released or a balloon fragment could be released which could pass naturally through the gi tract or be retrieved. if the extractor device is larger than the included syringe, the balloon under-inflation may occur, and no injury would be expected. if the skive location is above or below where labeled, then the user will see contrast emerge from the other location but still within the lumen. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2013.

Device

Extractor Pro XL Retrieval Balloon Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter
  • 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