BEUDAMED
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    Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·February 4, 2009

    Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011

    FDA Recall
    Terminated ·Datascope Corporation·Product code GEI·May 7, 2007

    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·February 16, 2017

    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020

    BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·July 27, 2017

    Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004

    FDA Recall
    Terminated ·Datascope Corporation·Product code GEI·May 7, 2007

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·February 21, 2018

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·May 9, 2016

    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·October 19, 2017

    BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604

    FDA Recall
    Terminated ·Datascope Corporation·Product code DTN·October 19, 2017

    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Recall
    Open, Classified ·Datascope Corporation·Product code DSP·July 27, 2020