BEUDAMED
    FDA Recall Terminated

    IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.

    Recall: Z-0462-2016 · Initiated November 20, 2015

    Recall

    Recall Number
    Z-0462-2016
    Event Number
    72721
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    OAD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 20, 2015
    Terminated
    November 27, 2019
    Address
    150 Baytech Dr, San Jose, CA, 95134-2302

    Description

    IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.

    Reason

    During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation.

    Action

    Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.

    Distribution

    Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.

    Quantity

    1556 - all models