Events

Recall of Device Recall Voyager

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

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
    31116
  • Event Risk Class
    Class 2
  • Event Number
    Z-0707-05
  • Event Initiated Date
    2005-01-27
  • Event Date Posted
    2005-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37178
  • 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
    Stent, Coronary - Product Code MAF
  • Reason
    Leak at guide wire exit notch could introduce air into the artery.
  • Action
    Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going.

Device

Device Recall Voyager
  • Model / Serial
    Catalog numbers apply in this recall situation as follows: Balloon Diameter (mm) Balloon Length (mm)  8 12 15 20 25 30 1.50 N/A 1011391-12 1011391-15 N/A N/A N/A 2.00 1011392-08 1011392-12 1011392-15 1011392-20 1011392-25 1011392-30 2.25 1011393-08 1011393-12 1011393-15 1011393-20 1011393-25 1011393-30 2.50 1011394-08 1011394-12 1011394-15 1011394-20 1011394-25 1011394-30 2.75 1011395-08 1011395-12 1011395-15 1011395-20 1011395-25 1011395-30 3.00 1011396-08 1011396-12 1011396-15 1011396-20 1011396-25 1011396-30 3.25 1011397-08 1011397-12 1011397-15 1011397-20 1011397-25 1011397-30 3.50 1011398-08 1011398-12 1011398-15 1011398-20 1011398-25 1011398-30  Column at the left represents the diameter. The last tow digits after the hyphen indicate the length.   Lot Numbers  The full list of lot numbers being recalled exceeds 1000. The scope of the recall involves all lots of the sizes given above that have lot numbers in the range:  40101XX through 41231XX, inclusive where XX can be any digits.   For reference lot numbers are date coded: YMMDDLS  Where Y=last digit of year manufactured, MM=month manufactured, DD=day manufactured, L=location manufactured, (5= Temecula CA, 3= Clonmel Ireland, S=sequence (1= first lot of day, 2= second lot of day).  TO IDENTIFY A UNIQUE PRODUCT ONE NEEDS BOTH THE PART NUMBER AND LOT NUMBER (MULTIPLE PART NUMBERS AER ASSIGNED THE SAME LOT NUMBER PER THE CONVENTION ABOVE.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide. Direct to customers in: Austria, Belgium & Luxumburg, Canada, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, The UK. To Distributors in: Finland, Iceland, Ireland, Lithuania, Barhain, Bulgaria, Cypres, Greece, Hungary, Israel, Jordan, Kuwait, Lebanon, Morocco, Poland, Russia, Saudi Arabia, South Africa, Syria, Tunisia, Turkey, UAE. Also countries in South and Central America although specifics are not known as above. Firm communicated with Competent Authorities in the 30 countries listed above.
  • Product Description
    Voyager RX Coronary Dilatation Catheter
  • Manufacturer
    Guidant Corporation Advanced CardiovascularSystem

Manufacturer

Guidant Corporation Advanced CardiovascularSystem
  • Manufacturer Address
    Guidant Corporation Advanced CardiovascularSystem, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA