Events

Recall of Atlantis PV Peripheral Imaging Catheter,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

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
  • Event ID
    50140
  • Event Risk Class
    Class 2
  • Event Number
    Z-0837-2009
  • Event Initiated Date
    2008-10-09
  • Event Date Posted
    2009-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74809
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    transducer, ultrasonic, diagnostic - Product Code ITX
  • Reason
    Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
  • Action
    Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.

Device

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

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