Events

Recall of Device Recall Atlantis PV 15 MHz 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
    67298
  • Event Risk Class
    Class 2
  • Event Number
    Z-0900-2014
  • Event Initiated Date
    2014-01-06
  • Event Date Posted
    2014-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125181
  • 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
    Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) y-manifold of the imaging catheter.
  • Action
    Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative.

Device

Device Recall Atlantis PV 15 MHz Peripheral Imaging Catheter
  • Model / Serial
    Product number: H749364560, Catalog number: 36456; Lot numbers:  16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution and Mexico
  • Product Description
    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: || Sterile, R; Sterilized using irradiation. || Product Usage: || This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 47215 Lakeview Blvd, Fremont CA 94538-6530
  • 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