Events

Recall of Device Recall Novoste BetaCath 3.5F System

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

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
    25139
  • Event Risk Class
    Class 2
  • Event Number
    Z-0462-03
  • Event Initiated Date
    2002-01-25
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25288
  • 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
    unknown device name - Product Code JAJ
  • Reason
    Mislabeling. source calibrated incorrectly, resultant dose rate lower than expected.
  • Action
    Customers were notified via Advisory Letter followed up with a Recall Letter and Customer Informational Letter on/about January 24, 2002. Customers were advised to discontinue use of the product and return the affected product to Novoste Corp. to be recalibrated to obtain a correct calibration certificate.

Device

Device Recall Novoste BetaCath 3.5F System
  • Model / Serial
    Catalog Numbers: TDA-0030 - Serial Numbers: 81431, 81761, 82548, 83007, 83926, 84395, 85014, 85021, 86333, 86489, 86874, 86889, 86897, 87097, 87103, 87189, 88592, 88692, 88734, 88738, 89035, 89037, 89058,  TDA-0040- Serial Numbers: 77252, 81012, 83214, 85327, 87816, 87834, 88591, 88598, 88617, 88622, 88626, 88632, 88681, 88697, 88691, 88697, 88702, 88712, 88718, 88719, 88720, 88721, 88736, 88739, 89045, 89049, 89054.
  • Distribution
    Nationwide. (AR, AZ, CA, FL, GA, IA, ID, IL, KY, MD, MI, MN, MO, NC, NM, NV, NY, OH, PA, TN, TX, VA, WA). No foreign or government accounts involved.
  • Product Description
    Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
  • Manufacturer
    Novoste Corporation

Manufacturer

Novoste Corporation
  • Manufacturer Address
    Novoste Corporation, 3890 Steve Reynolds Blvd., Norcross GA 30093
  • Source
    USFDA