BEUDAMED
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    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JHX·March 31, 2025

    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code DWF·October 14, 2021

    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code KFM·June 30, 2023

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code MMI·November 18, 2024

    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023

    ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023

    CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023

    ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·May 10, 2023

    CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·May 10, 2023