Device Recall Boston Scientific Extractor Pro XL Retrieval Balloon Catheter

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    USFDA

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Number:16231178
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
  • Description du dispositif
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above || UPN: M00547100 || The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: 16230354
  • Classification du dispositif
  • Distribution
    Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
  • Description du dispositif
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm || Injects Below || UPN :M00547140
  • Manufacturer