BEUDAMED
    FDA Recall Terminated

    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

    Recall: Z-1795-2014 · Initiated May 15, 2014

    Recall

    Recall Number
    Z-1795-2014
    Event Number
    68373
    Firm
    Boston Scientific Corporation
    FEI Number
    2939204
    Product Code
    OAD
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    May 15, 2014
    Posted
    June 16, 2014
    Terminated
    June 25, 2015
    Address
    47215 Lakeview Blvd, Fremont, CA, 94538-6530

    Description

    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

    Reason

    Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

    Action

    Customers were informed of the recall via overnight letter sent on May 15, 2014.

    Distribution

    Nationwide Distribution.

    Quantity

    968 units total all models