Events

Recall of Bard Stinger M Ablation Catheters

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-0599-03
  • 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=25760
  • 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 M Ablation Catheters
  • 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 M Ablation Catheters: || Item Numbers || 210001M 218501M || 210002M 218502M || 210003M 218503M || 210004M 218504M || 210005M 218505M || 210006M 218506M || 210007M 218507M || 210015M 218516M || 210016M 218518M || 210017M 218519M || 210018M 218520M || 210019M 218521M || 210020M 218523M || 210023M 218524M || 210024M 218525M || 210025M 218526M || 210026M 218527M || 210027M 218528M || 210028M 218529M || 210029M || 210030M
  • 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