BEUDAMED
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    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KRG·September 29, 2016

    The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KRG·September 29, 2016

    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code LWR·October 31, 2016

    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 12, 2020

    LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·November 18, 2019

    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DWF·April 24, 2020

    Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volume 6 liters. " One interchangeable heating/cooling circuit for cardioplegia heat-exchanger, temperatures ranging from 2 degrees Celsius to 10 degrees Celsius (cooling tank) and/or from 15 degrees Celsius to 41 degrees Celsius (heating tank). If required, the circuits for the patient and the circuit for cardioplegia can be switched off separately, in order to increase the activated functional group s heating and/or cooling performance. Product Usage: The Stockert Heater-Cooler System 3T is intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DWC·November 1, 2018

    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020