Imager II Angiographic Catheter

Manufacturer

  • Manufacturer Parent Company (2017)
  • 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
    DH

14 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot: 00116127, Expiration Date: September 30, 2018
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, FL, MO, NJ, NY, OH, PA, and TX.
  • Product Description
    Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
  • Manufacturer
  • Model / Serial
    Lot: 00112758, Use by 2018-05-11
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, KY, MO, NM, OK, OR, PA, and TX.
  • Product Description
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
  • Manufacturer
  • Model / Serial
    Multiple Lot numbers of the affected device are provided in the attached FSN.
  • Product Description
    Catheter
  • Manufacturer
9 more