Events

Recall of Flextome Cutting Balloon Monorail System;Peripheral Cutting Balloon microsurgical dilation device

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Boston Scientific.

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
    2005-12-14
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-dispositifs-cutting-balloon-de-la-societe-boston-scientific
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    The BOSTON Scientific company has withdrawn from the market on December 12, 2005, all batches of references cited in the appendix (12/12/2005) (82 KB), medical devices called Flextome Cutting Balloon Monorail System and Peripheral Cutting Balloon microsurgical dilation device This measurement follows reports of separation of the distal sheath of the Monorail catheter from the device during intervention on patients. The company has directly notified the recipients of the offending lot with the message attached (12/12/2005) (102 KB) validated by the Afssaps. This information is intended for the directors of health facilities and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Flextome Cutting Balloon Monorail System;Peripheral Cutting Balloon microsurgical dilation device

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
    LAANSM