Events

Recall of Device Recall Biosense NaviStar RMT Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioSense Webster, Inc..

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
    50784
  • Event Risk Class
    Class 2
  • Event Number
    Z-0368-2010
  • Event Initiated Date
    2008-10-02
  • Event Date Posted
    2009-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77277
  • 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
    radiofrequency ablation catheter, electrode recording catheter - Product Code LPB
  • Reason
    Biosense webster initiated the recall because of the potential concern with one of the printed circuit board (pcb) components used in the navistar rmt catheters, which may cause the ablation catheter icon to shift on the map viewer when rf energy is being applied. therefore the user, attempting a linear ablation in the location displayed on the carto rmt screen, may ultimately apply rf energy to u.
  • Action
    The firm sent an "Urgent Medical Device Correction" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay "close attention to the location of the ablation catheter icon on the map viewer when applying RF energy." If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement. Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.

Device

Device Recall Biosense NaviStar RMT Catheters
  • Model / Serial
    All lot numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI
  • Product Description
    Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02
  • Manufacturer
    BioSense Webster, Inc.

Manufacturer

BioSense Webster, Inc.
  • Manufacturer Address
    BioSense Webster, Inc., Circuito Interior Norte, #1820, Parque Industrial Salvarcar, Cd. Juarez, Chihuahua Mexico
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA