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    Alinity m System, Part No. 08N53-002

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code MZP·December 6, 2021

    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code MZP·July 7, 2004

    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV MonitorTest, Export, RUO.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code MZP·July 7, 2004

    Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MZP·May 21, 2007

    COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MZP·April 14, 2011

    COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human plasma or serum using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. The Test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MZP·April 14, 2011

    CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·November 17, 2009

    Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·May 17, 2007

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·April 27, 2015

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·July 2, 2015

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·February 9, 2015

    PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

    FDA Recall
    Terminated ·BIOSENSE WEBSTER·Product code MDT·April 22, 2020

    PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

    FDA Recall
    Terminated ·BIOSENSE WEBSTER·Product code MTD·April 22, 2020

    BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code BSY·November 22, 2021

    Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart.

    FDA Recall
    Terminated ·Biosense Webster Inc·Product code DRF·March 25, 2008

    Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code MTD·April 14, 2016

    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code MTD·April 14, 2016

    IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DRF·November 20, 2014

    CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·February 12, 2014

    Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart. 20 Poles, US Catalog Number D7L202515RT, EU Catalog Number 35T2515R

    FDA Recall
    Terminated ·Biosense Webster Inc·Product code DRF·March 25, 2008