BEUDAMED
    FDA Recall Terminated

    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.

    Recall: Z-1209-2015 · Initiated February 3, 2015

    Recall

    Recall Number
    Z-1209-2015
    Event Number
    70506
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    OAD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 3, 2015
    Posted
    March 2, 2015
    Terminated
    March 21, 2017
    Address
    150 Baytech Dr, San Jose, CA, 95134-2302

    Description

    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.

    Reason

    Reports of formation of char adherent to the proximal part of the distal tip electrodes

    Action

    Customer notification letters were sent by overnight mail on February 10, 2015.

    Distribution

    Distributed in Germany, Great Britain, and the Netherlands.

    Quantity

    14 units