BEUDAMED
    FDA Enforcement Class III Terminated

    CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia

    Recall: Z-1773-2019 · Reported June 19, 2019

    Enforcement

    Recall Number
    Z-1773-2019
    Event ID
    82803
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiocommand Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2019
    Initiation Date
    May 10, 2019
    Classification Date
    June 12, 2019
    Termination Date
    April 12, 2021
    Address
    4920 W Cypress St Ste 110, N/A, Tampa, FL, 33607-3837, United States

    Description

    CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia

    Reason

    Possible corrosion of the battery contact(s).

    Code Info

    Serial Numbers: 8059, 8060, 8022, 8063, 8211

    Distribution

    US Nationwide distribution in the states of CT, VW, OH, IL, DE.

    Quantity

    5 units