Events

Recall of Bard Stinger S 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-0600-03
  • 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=25761
  • 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 S 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 S Ablation Catheter: || Item Numbers || 210001S 218501S 6210015S || 210002S 218502S 6210016S || 210003S 218503S 6210017S || 210004S 218504S 6210018S || 210005S 218505S 6210019S || 210006S 218506S 6210020S || 210007S 218507S || 210015S 218516S || 210016S 218518S || 210017S 218519S || 210018S 218520S || 210019S 218521S || 210020S 218523S || 210023S 218524S || 210024S 218525S || 210025S 218526S || 210026S 218527S || 210027S 218528S || 210028S 218529S || 210029S || 210030S
  • 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