BEUDAMED
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    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·August 15, 2016

    Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. 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, Inc.·Product code MTD·February 20, 2014

    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·September 21, 2016

    Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping of cardiac structures.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·April 29, 2011

    ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT The ISMUS Catheter with Auto ID Technology has been designed for electrophysiological mapping of cardiac structures.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·April 29, 2011

    10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP recording system.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DQK·February 15, 2011

    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

    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DYB·February 15, 2017

    STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·July 7, 2011

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·November 22, 2010

    EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·November 22, 2010