Events

Field Safety Notices about 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Boston Scientific.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    V18469
  • Date
    2013-08-05
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/docs/default-source/field-safety-notices/jan-dec-2014-fsn-summary-sheets/fsnsummary_aug2013_qmsversion_updated_230714.pdf?sfvrsn=2
  • Notes / Alerts
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
  • Extra notes in the data
    Advice regarding a device removal. 3rd Party Publications

Device

4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device
  • Model / Serial
  • Product Description
    4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device
  • 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
    HPRA