Devices

Atlantis PV Peripheral Imaging Catheter,

  • Model / Serial
    Batch/lot #s 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including Puerto Rico and country of Panama
  • Product Description
    Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. || Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 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
    USFDA