BEUDAMED
    FDA Enforcement Class III Ongoing

    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    Recall: Z-0699-2019 · Reported January 16, 2019

    Enforcement

    Recall Number
    Z-0699-2019
    Event ID
    81747
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2019
    Initiation Date
    November 28, 2018
    Classification Date
    January 8, 2019
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291, United States

    Description

    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    Reason

    Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

    Code Info

    Blazer Open Irrigated Ablation Catheter Material Number: M00496200, Batch: 20399570, Expiration Date: 3/13/2020 Batch: 21778776, Expiration Date: 2/21/2021 Batch: 22152470, Expiration Date: 5/21/2021 Batch: 22499259, Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170, Expiration Date: 3/16/2020 Batch: 20809676, Expiration Date: 6/22/2020 Material Number: M0049620K20 Batch: 20403945, Expiration Date: 3/13/2020

    Distribution

    Japan

    Quantity

    1,282 (all three types in Japan)