BEUDAMED
    FDA Recall Terminated

    RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400. Indicated for use in cardiac ablation procedures.

    Recall: Z-0858-2009 · Initiated November 25, 2008

    Recall

    Recall Number
    Z-0858-2009
    Event Number
    50483
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 25, 2008
    Posted
    January 14, 2009
    Terminated
    April 26, 2011
    Address
    150 Baytech Dr, San Jose, CA, 95134-2302

    Description

    RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400. Indicated for use in cardiac ablation procedures.

    Reason

    Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.

    Action

    Recall initiated on November 25, 2008. Urgent Company Initiated Medical Device Recall - Immediate Action Required letters, dated 11/26/2008, were sent to consignees via Federal Express and included return and reply forms for consignees to respond. The letters asked that further distribution or use of any foot switch affected by this recall be ceased immediately. Attached to the letter was a document entitled "Instructions for Determining Affected Product," which provided instructions and serial numbers for determining if customers have product affected by this recall. In addition, a document entitled "Recall Instructions" was also attached. Affected product should be segregated and returned to Boston Scientific in accordance to the "Recall Instructions," and the Reply and Verification Tracking Form should be completed and returned. Customers will receive replacement product for all recalled product returned to Boston Scientific. Local Sales Reps should be contacted in regards to any questions customers may have pertaining to this recall.

    Distribution

    Worldwide Distribution --- including USA and countries of France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya.

    Quantity

    322 units