Cardiac ablation percutaneous catheter
FDA product code LPB · Class 3 · 109 devices · 8,349 reports · 346 deaths reported · 2 devices named in recalls
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
- ThermoCool SmartTouch D133601Biosense Webster Inc · Cardiac ablation percutaneous catheter10 deaths162 reports
- ThermoCool SmartTouch D132704Biosense Webster Inc · Cardiac ablation percutaneous catheter7 deaths121 reports
- EZ Steer NAV BN7TCDF4LBiosense Webster Inc · Cardiac ablation percutaneous catheter2 deaths105 reports
- SmartAblateTM System RF Generator M490007Stockert GmbH · Cardiac Ablation Percutaneous Catheter20 deaths73 reports
- THERMOCOOL SMARTTOUCH SF D134703Biosense Webster Inc · Cardiac ablation percutaneous catheter3 deaths72 reports
- Maestro 4000™ Controller M00440000Boston Scientific Corporation · Cardiac ablation percutaneous catheter55 reports
- Ampere™ H700488St. Jude Medical, Inc. · Cardiac ablation percutaneous catheter54 reports
- N/A 2035UMedtronic, Inc. · Cardiac ablation percutaneous catheter1 recall1 report
- ThermoCool SmartTouch D132701Biosense Webster Inc · Cardiac ablation percutaneous catheter51 reports
- nGEN Generator D138402Biosense Webster Inc · Cardiac ablation percutaneous catheter2 deaths46 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter41 reports
- EZ Steer NAV BN7TCFJ4LBiosense Webster Inc · Cardiac ablation percutaneous catheter24 reports
- ThermoCool SmartTouch D133603Biosense Webster Inc · Cardiac ablation percutaneous catheter1 death23 reports
- SmartAblateTM System Irrigation Pump M490008Stockert GmbH · Cardiac Ablation Percutaneous Catheter22 reports
- THERMOCOOL SMARTTOUCH SF D134802Biosense Webster Inc · Cardiac ablation percutaneous catheter20 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter19 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter18 reports
- nGEN Pump D139702Biosense Webster Inc · Cardiac ablation percutaneous catheter17 reports
- EZ Steer BD7TCDF4LBiosense Webster Inc · Cardiac ablation percutaneous catheter15 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter14 reports
- Blazer® II HTD M0045031TH0Boston Scientific Corporation · Cardiac ablation percutaneous catheter14 reports
- EZ Steer DS BD7TCFJ8LBiosense Webster Inc · Cardiac ablation percutaneous catheter14 reports
- Safire™ 402810St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter12 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter11 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter10 reports
- IntellaNav™ ST M004R5031TH0Boston Scientific Corporation · Cardiac ablation percutaneous catheter10 reports
- Safire™ 402811St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter9 reports
- ThermoCool SF NAV D131503Biosense Webster Inc · Cardiac ablation percutaneous catheter9 reports
- Freezor™ Xtra 217F3Medtronic, Inc. · Cardiac ablation percutaneous catheter7 reports
- Safire™ 402807St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter7 reports
- Blazer® II HTD M0045031THK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter7 reports
- ThermoCool SmartTouch D132702Biosense Webster Inc · Cardiac ablation percutaneous catheter7 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter6 reports
- ThermoCool SF NAV D131802Biosense Webster Inc · Cardiac ablation percutaneous catheter6 reports
- NA 2035UCMedtronic, Inc. · Cardiac ablation percutaneous catheter6 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter5 reports
- Maestro 4000™ Pod, 100W M00440100Boston Scientific Corporation · Cardiac ablation percutaneous catheter5 reports
- IntellaNav™ ST M004R5031THK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter5 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter4 reports
- Freezor® Xtra 227F3Medtronic, Inc. · Cardiac ablation percutaneous catheter4 reports
- Livewire™ 402151St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter4 reports
- Blazer® II M0045031T0Boston Scientific Corporation · Cardiac ablation percutaneous catheter4 reports
- Celsius D7TCDL252RTBiosense Webster Inc · Cardiac ablation percutaneous catheter4 reports
- ThermoCool SF NAV D131502Biosense Webster Inc · Cardiac ablation percutaneous catheter4 reports
- THERMOCOOL SMARTTOUCH SF D134803Biosense Webster Inc · Cardiac ablation percutaneous catheter4 reports
- NA 203CXMedtronic, Inc. · Cardiac ablation percutaneous catheter3 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter3 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter3 reports
- Blazer® II M0045031TK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter3 reports
- Blazer Prime® HTD M004P5031TH0Boston Scientific Corporation · Cardiac ablation percutaneous catheter3 reports
- Maestro 4000™ Controller M0044000H0Boston Scientific Corporation · Cardiac ablation percutaneous catheter3 reports
- Celsius D7TCFL252RTBiosense Webster Inc · Cardiac ablation percutaneous catheter3 reports
- EZ Steer NAV BN7TCFF4LBiosense Webster Inc · Cardiac ablation percutaneous catheter3 reports
- NaviStar RMT NR7TCS4YUBiosense Webster Inc · Cardiac ablation percutaneous catheter1 death3 reports
- ThermoCool SF NAV D131803Biosense Webster Inc · Cardiac ablation percutaneous catheter2 deaths3 reports
- Freezor™ Xtra 217F5Medtronic, Inc. · Cardiac ablation percutaneous catheter2 reports
- Nitron CryoConsole™Medtronic, Inc. · Cardiac ablation percutaneous catheter2 reports
- Livewire™ 402152St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter2 reports
- Safire™ 402806St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter2 reports
- Therapy™ IBI-83366Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter2 reports
- Ampere™ Remote ControlSt. Jude Medical, Inc. · Cardiac ablation percutaneous catheter2 reports
- Blazer® II M0045031TK10Boston Scientific Corporation · Cardiac ablation percutaneous catheter2 reports
- Blazer Prime® HTD M004P5031THN40Boston Scientific Corporation · Cardiac ablation percutaneous catheter2 reports
- Celsius D7TDL252RTBiosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- Celsius D7TFL252RTBiosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- EZ Steer DS BD7TCDF8LBiosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- EZ Steer NAV BN7TCJJ4LBiosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- Celsius D7TCL252RTBiosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- NaviStar RMT NR7TCS4YBiosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- ThermoCool SF NAV D131501Biosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- ThermoCool SF D131603Biosense Webster Inc · Cardiac ablation percutaneous catheter2 reports
- RF Marinr™ 075302Medtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- NA 203CXMedtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- NA 2037AMedtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- Freezor® 307F3Medtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- Freezor® Xtra 227F5Medtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- NA 2037AMedtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- NA 2035UMedtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- Freezor™ Xtra 217F1Medtronic, Inc. · Cardiac ablation percutaneous catheter1 report
- Safire™ 402808St. Jude Medical Cardiovascular Division · Cardiac ablation percutaneous catheter1 report
- Therapy™ IBI-83365Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter1 report
- SJM™ IBI-85641Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter1 report
- Cool Point™ H701666Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter1 report
- Blazer® II HTD M0045031THN40Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer® II M0045031TL0Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer® II M0045770TN40Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer® II HTD M0045086THK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer® II M0045086TK10Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Blazer Prime® HTD M004P5031THK20Boston Scientific Corporation · Cardiac ablation percutaneous catheter1 report
- Celsius D7TCBL252RTBiosense Webster Inc · Cardiac ablation percutaneous catheter1 report
- EZ Steer BD7TCFJ4LBiosense Webster Inc · Cardiac ablation percutaneous catheter1 report
- EZ Steer NAV BN7TCDD4LBiosense Webster Inc · Cardiac ablation percutaneous catheter1 report