Device Recall IMAGER II Angiographic Catheters

  • Modèle / numéro de série
    Lot: 00116127, Expiration Date: September 30, 2018
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    AZ, FL, MO, NJ, NY, OH, PA, and TX.
  • Description du dispositif
    Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Boston Scientific Corporation, 2 Scimed Pl, Maple Grove MN 55311-1565
  • 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