Events

Recall of Device Recall Polaris Dx Diagnostic Catheter

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

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
    38351
  • Event Risk Class
    Class 3
  • Event Number
    Z-1191-2007
  • Event Initiated Date
    2007-06-26
  • Event Date Posted
    2007-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53472
  • 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
    Diagnostic Cardiac Catheter - Product Code DRF
  • Reason
    Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
  • Action
    The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it.

Device

Device Recall Polaris Dx Diagnostic Catheter
  • Model / Serial
    Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 3 consignees in Florida and Tennessee.
  • Product Description
    Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 2710 Orchard Pkwy, San Jose CA 95134
  • Source
    USFDA