BEUDAMED
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    VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.

    FDA Recall
    Terminated ·Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic·Product code KRA·November 20, 2003

    Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    DTX(tm) Plus DT-DL60 Continuous flush catheter

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    DT-DL60-1 W/Bifurcated

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code KRA·August 10, 2005

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·October 5, 2016

    ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

    FDA Recall
    Terminated ·Vascular Insights, LLC·Product code KRA·November 9, 2017

    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code KRA·November 8, 2019

    EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150

    FDA Recall
    Terminated ·Ekos Corp·Product code KRA·February 9, 2007

    MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.

    FDA Recall
    Terminated ·Cordis Corporation·Product code KRA·June 30, 2008

    CRITIFLOW(tm) TA4004 continuous flush catheter

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code KRA·February 9, 2009

    Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011

    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·October 2, 2013

    Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932 Benephit Infusion Systems are intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury, and whom arterial catheterization for TRT is feasible.

    FDA Recall
    Terminated ·Angiodynamics Worldwide Headquarters·Product code KRA·December 5, 2011

    Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·December 6, 2013