Events

Recall of Ultra-soft SV Monorail balloon dilatation catheters

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
    2003-08-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappels-de-plusieurs-types-de-dispositifs-medicaux-effectues-par-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
    In August, Boston informed Afssaps that it was recalling several types of medical devices. AFSSAPS has not been reported to have a materiovigilance incident concerning these devices in France. Afssaps asked the Boston company to provide explanatory information on the origin of these recalls. All DSB Detachable Silicone Balloon Packs, Endeavor Non-Detachable Silicone Balloons, Coaxial Angiographic Catheter Set, Hieshima Taper Select Infusion Catheters, Coaxial Introduction Catheters, Discharge Chucks, Discharge Tubes. Technical data do not confirm the expiry date applied to the products. These devices are commonly used in medical imaging and interventional neuroradiology. The attached letter (07/08/2003) (191 KB) was sent on August 7th to the 17 user centers. Recall of 21 batches of Ultra-soft SV Monorail balloon dilatation catheters: The attached mail (04/08/2003) (181 KB) was sent on August 4th to the 27 user centers. Reminder of 30 batches of pre-assembled Stents Express Vascular SD: the attached mail (04/08/2003) (180 KB) was sent on August 4th to the 44 user centers. These two reminders are motivated by the fact that the closure of certain packets of devices is damaged. This may affect the sterility of the device. Recall of 6 batches of Maxforce TTS single use balloon dilators due to incorrect product identification. These devices are used for esophageal dilatation. The attached mail (14/08/2003) (204 KB) was sent on August 13 to the 6 user centers.

Device

Ultra-soft SV Monorail balloon dilatation catheters

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