Events

Recall of OffRoad Re-Entry Catheter System

According to Republic of Lebanon Ministry of Public Health, this recall involved a device in Lebanon that was produced by Boston Scientific International S.A..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2014-10-20
  • Event Country
    Lebanon
  • Event Source
    RLMPH
  • Event Source URL
    https://www.moph.gov.lb/userfiles/medical_care/OffRoad.pdf
  • Notes / Alerts
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
  • Extra notes in the data

Device

OffRoad Re-Entry Catheter System

Manufacturer

Boston Scientific International S.A.
  • 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.”
  • Manufacturers representative
    Medilife s.a.l.
  • Source
    RLMPH