BEUDAMED
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    BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

    FDA Recall
    Open, Classified ·Becton Dickinson Infusion Therapy Systems Inc.·Product code FOZ·September 8, 2021

    HeartWare HVAD Pump Kit, REF MCS1705PU

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare HVAD Pump Kit, REF 1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·May 16, 2023

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·March 1, 2024

    Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·April 3, 2020

    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·February 26, 2021

    Medtronic HVAD Pump Implant Kits

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·August 6, 2021

    Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·October 22, 2021

    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·February 26, 2021

    HeartWare HVAD Pump Implant Kit, REF 1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·June 3, 2021

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Recall
    Open, Classified ·HeartWare Inc·Product code DSQ·April 29, 2015

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Recall
    Open, Classified ·HeartWare Inc·Product code DSQ·April 29, 2015

    HeartWare HVAD Pump Kit, REF 1104CA-CLIN

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·March 1, 2024

    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·October 31, 2023

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HDQ·December 3, 2024

    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No

    FDA Recall
    Open, Classified ·Thoratec LLC·Product code DSQ·October 9, 2025

    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    FDA Recall
    Open, Classified ·HeartWare, Inc·Product code DSQ·August 17, 2016