BEUDAMED
    252 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

    FDA Recall
    Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code GWJ·November 6, 2025

    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

    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.

    FDA Recall
    Terminated ·Abbott·Product code OAE·May 22, 2020

    Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    EZ Steer ThermoCool Nav Part Number D-1292-03-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

    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·March 19, 2015

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·March 24, 2022

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·March 24, 2022

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    EZ Steer ThermoCool Nav Part Number D-1292-05-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

    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.

    FDA Recall
    Terminated ·Product code OAE·November 25, 2014

    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·June 9, 2022

    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024