BEUDAMED
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    Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430

    FDA Recall
    Terminated ·Datascope Corp·Product code DSP·November 19, 2007

    Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ

    FDA Recall
    Terminated ·Datascope Corporation·Product code MHX·October 9, 2007

    CS 100 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    CS 100i Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    CS 300 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DSP·March 27, 2012

    Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code FMZ·March 16, 2011

    Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

    FDA Enforcement
    Class II ·Terminated·Datascope Corp.·November 13, 2019

    Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·June 16, 2005

    10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.

    FDA Recall
    Terminated ·Datascope Corp·Product code DSP·March 21, 2003

    Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

    FDA Recall
    Terminated ·Datascope Corp·Product code MSX·April 5, 2004

    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·August 19, 2005

    Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

    FDA Recall
    Terminated ·Datascope Corp.·Product code MHX·October 3, 2019

    Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·September 7, 2005

    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·July 28, 2004

    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

    FDA Recall
    Terminated ·Datascope Corp·Product code NWI·September 24, 2004

    Anestar and Anestar Plus Anesthesia System.

    FDA Recall
    Terminated ·Datascope Corp·Product code BSZ·March 17, 2006

    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    FDA Recall
    Terminated ·Datascope Corp·Product code MHX·December 7, 2005

    Anestar Anesthesia Delivery System

    FDA Recall
    Terminated ·Datascope Corp·Product code BSZ·June 24, 2003

    Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2.

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·September 7, 2005