BEUDAMED
    FDA Recall Terminated

    Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.

    Recall: Z-1102-06 · Initiated May 22, 2006

    Recall

    Recall Number
    Z-1102-06
    Event Number
    35515
    Firm
    Boston Scientific
    FEI Number
    3002095335
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2006
    Posted
    June 10, 2006
    Terminated
    December 30, 2006
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.

    Reason

    Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.

    Action

    Affected customers were mailed an Urgent Medical Device Recall or Correction - Immediate Action Required letter, dated 05/22/2006. The letter describes the issue, states to immediately discontinue use of and segregate recalled product, provides instructions to ship product back to Boston Scientific and asks for the Reply Verification Tracking Form to be faxed to Boston Scientific in acknowledgement.

    Distribution

    Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.

    Quantity

    75