Events

Safety Alert for Lotus Valve Systems

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
    2016-04-15
  • Event Date Posted
    2016-04-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160415.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 lotus valve systems medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its lotus valve systems [material number (upn): h749ltv230, h749ltv250, h749ltv270; catalogue number: ltv23, ltv25, ltv27; batch number: all batches]. boston scientific is implementing a voluntary field safety notice to reinforce the training requirements associated with the use of the lotus valve system. a recent investigation identified a number of sites that had performed lotus valve cases without the mandatory support of a boston scientific field clinical specialist (bsc fcs). all lotus valve cases must be supported a bsc fcs until the site is designated as “independent” by the manufacturer. in order for a site to be designated as independent, the following must be complete: two physicians must be certified, i.E. they must have attended face to face training; performed a minimum of six lotus valve cases with a proctor and a bsc fcs and performed a minimum of four additional lotus valve cases with a bsc fcs two catheterisation laboratory staff must be certified to prepare the lotus valve certified physicians must be trained on advances techniques by bsc sites that are not designated as “independent” are instructed not to perform lotus valve cases without the support of a bsc fcs. no product is being recalled as there is no impact to previously implanted devices. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 april 2016.

Device

Lotus Valve Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Lotus Valve Systems
  • 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