Events

Recall of Device Recall Bard SSV Split Sheath with Valve Introducer System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C. R.Bard, Inc./BardElectrophysiology 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
    49575
  • Event Risk Class
    Class 2
  • Event Number
    Z-0280-2009
  • Event Initiated Date
    2008-10-01
  • Event Date Posted
    2008-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73831
  • 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
    Catheter introducer - Product Code DYB
  • Reason
    Failure to insert the guidewire through the introducer needle.
  • Action
    Bard issued a recall notice on 1 October 2008 [note that the letter is dated 29 September 2008] to all recipients of affected product via certified mail. Users are requested to discontinue use and return inventory. Contact Bard Customer Service at 1-800-824-8724 for assistance.

Device

Device Recall Bard SSV Split Sheath with Valve Introducer System
  • Model / Serial
    Lot Numbers: S25589 and S26178
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    7F Bard SSV 13 cm Split Sheath with Valve and sideport || Catalog Number: 808700 || Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and catheters
  • Manufacturer
    C. R.Bard, Inc./BardElectrophysiology Division

Manufacturer

C. R.Bard, Inc./BardElectrophysiology Division
  • Manufacturer Address
    C. R.Bard, Inc./BardElectrophysiology Division, 55 Technology Dr, Lowell MA 01851-5203
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA