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
  • 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
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Part Number: 1011759-08, Lot Numbers: 8050961 and 8062361.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
  • Manufacturer
  • Model / Serial
    Part Number: 1011759-12, Lot Numbers: 8041051, 8050561, 8061961 and Part Number: 1011750-12, Lot Number 8100761.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
  • Manufacturer