BEUDAMED
    FDA Enforcement Class I 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 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1209-2015
    Event ID
    70506
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    February 3, 2015
    Classification Date
    March 2, 2015
    Termination Date
    March 21, 2017
    Address
    150 Baytech Dr, N/A, San Jose, CA, 95134-2302, United States

    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

    Code Info

    Material number: M004EPM96200, Catalog Number EPM9620; Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879. Material number: M004EPM9620K20, Catalog Number: EPM9620K2: Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714. Material number : M004EPM9620N40; Catalog number: EPM9620N4; Serial numbers: 17148152, 17226126, 17266642. All with Expiry Dates of April 20, 2015 - June 14, 2015.

    Distribution

    Distributed in Germany, Great Britain, and the Netherlands.

    Quantity

    14 units