BEUDAMED
    FDA Enforcement Class II 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 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1795-2014
    Event ID
    68373
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 15, 2014
    Classification Date
    June 16, 2014
    Termination Date
    June 25, 2015
    Address
    47215 Lakeview Blvd, N/A, Fremont, CA, 94538-6530, United States

    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.

    Code Info

    Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017

    Distribution

    Nationwide Distribution.

    Quantity

    968 units total all models