BEUDAMED
    FDA Recall Terminated

    Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.

    Recall: Z-1437-04 · Initiated August 16, 2004

    Recall

    Recall Number
    Z-1437-04
    Event Number
    29876
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 16, 2004
    Posted
    September 2, 2004
    Terminated
    March 31, 2005
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.

    Reason

    Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.

    Action

    Sales Representative to provide letter to each of the 25 US customers explaining the action. Sales Representatives will remove any affected product from customers inventory. Certification records will be completed for each customer confirming the removal action. International affiliates to conduct similar actions.

    Distribution

    Nationwide and Japan, Europe, & Uruguay

    Quantity

    848