Cardiac Ablation Percutaneous Catheter
FDA product code LPB · Class III (high risk) · Cardiovascular
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
0510(k) clearances
13PMA approvals
19recalls
PMA approvals
- P240014 MAGiC Ablation Catheter · Stereotaxis, Inc. · 01/05/2026
- P050029 Helios II Ablation Catheter · Stereotaxis, Inc. · 10/10/2008
- P040036 Navistar Thermocool Deflectable Diagnostic/Ablation Catheter · Biosense Webster, Inc. · 08/11/2006
- P040014 Ibi Therapy Cardiac Ablation System Ers/ 1500T RF Generator · Irvine Biomedical, Inc. · 01/14/2005
- P020045 7F Freezor Cardiac Cryoablation Catheter and CCT.2 Cryoconsole System · Medtronic Cryocath, LP · 04/17/2003
- P000020 Stinger Ablation Catheter; Templink Extension Cable · Boston Scientific Corp · 11/29/2000
- P990071 Stockert 70 Radiofrequency Ablation Generator · Biosense Webster, Inc. · 05/31/2000
- P990054 Chilli Cooled Ablation System · Boston Scientific Corp · 03/17/2000
- P960016 Livewire(R) Cardiac Ablation System · St Jude Medical · 05/04/1999
- P980003 Chilli Cooled RF Ablation System · Boston Scientific Corp · 02/02/1999
- P950005 Webster Diag./Ablation Deflectable Tip Catheter · Biosense Webster, Inc. · 09/30/1997
- P930029 Atakr(Tm) Rfca System · Medtronic, Inc. · 02/09/1995
- P920047 EPT-1000 Cardiac Ablation System · Boston Scientific Corp · 10/28/1994
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0058-2018 Class II | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-SBiosense Webster, Inc. has recently received an increased number of complaints related to the display of… | Biosense Webster, Inc. | 09/06/2017Terminated |
| Z-0057-2018 Class II | THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | Biosense Webster, Inc. | 09/06/2017Terminated |
| Z-0056-2018 Class II | THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | Biosense Webster, Inc. | 09/06/2017Terminated |
| Z-0055-2018 Class II | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S…Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | Biosense Webster, Inc. | 09/06/2017Terminated |
| Z-0054-2018 Class II | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S…Biosense Webster, Inc. has recently received an increased number of complaints related to the display of… | Biosense Webster, Inc. | 09/06/2017Terminated |
| Z-0210-2018 Class II | SMARTABLATE RF System GeneratorGenerator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented… | Biosense Webster, Inc. | 06/14/2017Terminated |
| Z-2777-2015 Class II | Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac…An issue with a USB memory component contained within a subset of CryoConsoles can result in extended… | Medtronic Inc. Cardiac Rhythm Disease… | 09/01/2015Terminated |
| Z-0139-2015 Class II | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703…The recall was initiated because Biosense Webster is providing additional labeling for the safe and… | Biosense Webster, Inc. | 10/19/2014Terminated |
| Z-3178-2011 | STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a…Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio… | Biosense Webster, Inc. | 07/07/2011Terminated |
| Z-3257-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726…The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip… | St Jude Medical | 02/10/2011Terminated |
| Z-3256-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725…The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip… | St Jude Medical | 02/10/2011Terminated |
| Z-3255-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724…The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip… | St Jude Medical | 02/10/2011Terminated |
| Z-0170-2011 | Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with…Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation… | Boston Scientific Corporation | 09/27/2010Terminated |
| Z-1156-2010 | CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number…Product failure-- Product may cease operation as a result of potential speed control board failure when the… | Boston Scientific Corp | 09/22/2009Terminated |
| Z-0973-2011 | RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model…Product malfunction causes inadvertent delivery of energy. | Boston Scientific Corp | 07/14/2009Terminated |
| Z-0858-2009 | RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and…Product malfunction may result in delivery of energy without depressing the foot switch that controls… | Boston Scientific Corp | 11/25/2008Terminated |
| Z-0369-2010 | Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part…Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board… | BioSense Webster, Inc. | 10/02/2008Terminated |
| Z-0368-2010 | Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part…Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board… | BioSense Webster, Inc. | 10/02/2008Terminated |
| Z-2313-2008 | The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor…St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was… | St. Jude Medical Cardiovascular Division | 06/05/2008Terminated |