Events

Safety Alert for Vessix Generator System

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
    2013-11-13
  • Event Date Posted
    2013-11-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131113.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 vessix generator system medical device manufacturer, boston scientific corporation has issued a medical device safety alert concerning a recall of vessix generator system with catalogue number rdns010 and the following serial numbers: 42002, 42003, 42005, 42006, 42015, 42019, 42027, 42030, 42033, 42038, 42039, 42043, 42045, 42047, 42059, 42062, 42067, 42068, 42070 an investigation has found that the units manufactured since april 2013 were not manufactured according to specification. this manufacturing issue may cause an electrical short in the generator. the recall affects the generator only and does not impact the vessix renal denervation catheter or other components of the system. boston scientific explains that this issue could result in excessive radiofrequency energy being delivered to the renal artery and subsequently lead to thrombosis formation, nerve damage and thermal damage to the renal artery or adjacent structures. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 november 2013.

Device

Vessix Generator System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Vessix Generator System
  • 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