Events

Recall of Bard Orbiter ST Artrial Mapping Steerable Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C. R.Bard, Inc./Electrophysiology Division.

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
    25401
  • Event Risk Class
    Class 2
  • Event Number
    Z-0602-03
  • Event Initiated Date
    2003-01-08
  • Event Date Posted
    2003-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25763
  • 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
  • Reason
    Sterile barrier maybe perforated compromising sterility of the device.
  • Action
    Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.

Device

Bard Orbiter ST Artrial Mapping Steerable Catheter
  • Model / Serial
    All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
  • Distribution
    Nationwide
  • Product Description
    Bard Orbiter ST Artrial Mapping Steerable Catheter || Item Numbers || 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B 7FAM0017B || 320002 7FAM00002 7FAM00011 7FAM00020 7FAM0009B 7FAM0018B || 320003 7FAM00003 7FAM00012 7FAM0001B 7FAM0010B 7FAM0019B || 320004 7FAM00004 7FAM00013 7FAM0002B 7FAM0011B 7FAM0020B || 320005 7FAM00005 7FAM00014 7FAM0003B 7FAM0012B || 320006 7FAM00006 7FAM00015 7FAM0004B 7FAM0013B || 320007 7FAM00007 7FAM00016 7FAM0005B 7FAM0014B || 320008 7FAM00008 7FAM00017 7FAM0006B 7FAM0015B || 320009 7FAM00009 7FAM00018 7FAM0007B 7FAM0016B
  • Manufacturer
    C. R.Bard, Inc./Electrophysiology Division

Manufacturer

C. R.Bard, Inc./Electrophysiology Division
  • Manufacturer Address
    C. R.Bard, Inc./Electrophysiology Division, 129 Concord Road, Billerica MA 01821
  • Source
    USFDA