Events

Recall of Bard Stinger SM 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-0601-03
  • 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=25762
  • 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 SM 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 SM Ablation Catheter || Item Numbers || 210001SM 218501SM || 210002SM 218502SM || 210003SM 218503SM || 210004SM 218504SM || 210005SM 218505SM || 210006SM 218506SM || 210007SM 218507SM || 210015SM 218516SM || 210016SM 218518SM || 210017SM 218519SM || 210018SM 218520SM || 210019SM 218521SM || 210020SM 218523SM || 210023SM 218524SM || 210024SM 218525SM || 210025SM 218526SM || 210026SM 218527SM || 210027SM 218528SM || 210028SM 218529SM || 210029SM || 210030SM
  • 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