Z-0707-05

Voyager RX Coronary Dilatation Catheter

Name: Z-0707-05 Voyager RX Coronary Dilatation Catheter
Creator: Guidant Corporation Advanced CardiovascularSystem
Published: 2005-01-27
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2005-01-27 / Terminated

FDA source

Guidant Corporation Advanced CardiovascularSystem began a recall of Voyager RX Coronary Dilatation Catheter on 2005-01-27. The reason FDA records is "Leak at guide wire exit notch could introduce air into the artery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0707-05
Status: Terminated
Initiated: 2005-01-27
Posted: 2005-04-13
Terminated: 2012-03-29
Recalling firm: Abbott Vascular
Product: Voyager RX Coronary Dilatation Catheter
Product code: MAF Stent, Coronary
Reason for recall: Leak at guide wire exit notch could introduce air into the artery.
FDA root cause: Other
Action: Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going.
Quantity in commerce: 180,000 units
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 codes and lots: 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 code MAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)