Guidant Corporation Advanced CardiovascularSystem Voyager RX Coronary Dilatation Catheter Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Voyager RX Coronary Dilatation Catheter
Brand
Guidant Corporation Advanced CardiovascularSystem
Lot Codes / Batch Numbers
MM=month manufactured, DD=day manufactured, L=location manufactured, (5= Temecula CA, 3= Clonmel Ireland, S=sequence (1= first lot of day
Products Sold
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.
Guidant Corporation Advanced CardiovascularSystem is recalling Voyager RX Coronary Dilatation Catheter due to Leak at guide wire exit notch could introduce air into the artery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Leak at guide wire exit notch could introduce air into the artery.
Recommended Action
Per FDA guidance
Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026