Events

Recall of DuoDecapolar Electrophysiology Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosense Webster, Inc..

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
    59465
  • Event Risk Class
    Class 3
  • Event Number
    Z-3038-2011
  • Event Initiated Date
    2011-04-29
  • Event Date Posted
    2011-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102844
  • 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
    Catheter, electroderecording, or probe, electrode recording - Product Code DRF
  • Reason
    The recall was expanded because between february and april 2011, biosense webster, inc. notified customers that a voluntary customer notification had been initiated due to the inaccessibility of the electronic version of the instructions for use (e-ifu) for the "10 ft. interface cable, 10 pin - shielded tip pins to 12 pin - blue", catalog number 0128709, through the j&j; gateway (i.E., e-ifu websi.
  • Action
    Biosense Webster sent an "URGENT FIELD SAFETY NOTICE" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm. The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense. Customers with questions or require additionial information were instructed to contact their Biosense Webster representative.

Device

DuoDecapolar Electrophysiology Catheter
  • Model / Serial
    Not available
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT || Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping of cardiac structures.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA