BEUDAMED
    FDA Recall Terminated

    Voyager RX Coronary Dilatation Catheter

    Recall: Z-0707-05 · Initiated January 27, 2005

    Recall

    Recall Number
    Z-0707-05
    Event Number
    31116
    Firm
    Guidant Corporation Advanced CardiovascularSystem
    FEI Number
    2024168
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2005
    Posted
    April 13, 2005
    Terminated
    March 29, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Voyager RX Coronary Dilatation Catheter

    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.

    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.

    Quantity

    180,000 units