BEUDAMED
    FDA Recall 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 · Initiated May 10, 2019

    Recall

    Recall Number
    Z-1773-2019
    Event Number
    82803
    Firm
    Cardiocommand Inc.
    FEI Number
    1927197
    Product Code
    LPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 10, 2019
    Terminated
    April 12, 2021
    Address
    4920 W Cypress St, Ste 110, Tampa, FL, 33607-3837

    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).

    Action

    The consignees were notified by letter on 05/10/2019. The notice requested the return of the unit.

    Distribution

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

    Quantity

    5 units