Events

Recall of 7FR Deflectable Tip Catheter and 5FR Deflectable Tip 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
    29876
  • Event Risk Class
    Class 2
  • Event Number
    Z-1437-04
  • Event Initiated Date
    2004-08-16
  • Event Date Posted
    2004-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34709
  • 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, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
  • Reason
    Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
  • Action
    Sales Representative to provide letter to each of the 25 US customers explaining the action. Sales Representatives will remove any affected product from customers inventory. Certification records will be completed for each customer confirming the removal action. International affiliates to conduct similar actions.

Device

7FR Deflectable Tip Catheter and 5FR Deflectable Tip Catheter
  • Model / Serial
    112 lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Japan, Europe, & Uruguay
  • Product Description
    Deflectable Tip Catheter for cardiac mapping. || Mfg Part # Catalog # EU Part # || D-1078-35-S 107835S SW1078-035; || D-1078-63-S D5S06AL252RT 36A-07Q; || D-1078-78-S 107878S N/A; || D-1097-511-S 1097511S SW1097-511; || D-1097-554-S D708DL002RT 36F-32Q.
  • 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