Events

Recall of Bard Stinger Ablation 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-0598-03
  • 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=25759
  • 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 Stinger Ablation 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 Stinger Ablation Catheter: || Item Numbers || 210001 218501 L210001 || 210002 218502 L210002 || 210003 218503 L210003 || 210004 218504 L210004 || 210005 218505 L210005 || 210006 218506 L210006 || 210007 218507 L210007 || 210015 218516 L210008 || 210016 218518 L210009 || 210017 218519 L210010 || 210018 218520 L210011 || 210019 218521 L210012 || 210020 218523 L210013 || 210023 218524 L210014 || 210024 218525 L210015 || 210025 218526 L210016 || 210026 218527 L210017 || 210027 218528 L210018 || 210028 218529 || 210029 || 210030
  • 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