Biosense Webster Inc
217 devices · 18,066 adverse event reports · 445 deaths reported · 16 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- THERMOCOOL SMARTTOUCH SF D134805Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- VIZIGO D138502INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- QDOT MICRO D139505catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- THERMOCOOL SMARTTOUCH SF D134804Cardiac ablation percutaneous catheter44 deaths784 reports
- PENTARAY NAV D128211CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls6 deaths551 reports
- THERMOCOOL SMARTTOUCH SF D134801Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Cardiac ablation percutaneous catheter19 deaths366 reports
- VIZIGO D138503INTRODUCER, CATHETER362 reports
- PENTARAY NAV D128208CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls2 deaths237 reports
- VARIPULSE™ Bi-Directional Catheter D141201Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall3 deaths273 reports
- CARTO VIZIGO D138504Introducer, catheter2 deaths288 reports
- THERMOCOOL SMARTTOUCH SF D134701Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Cardiac ablation percutaneous catheter185 reports
- QDOT MICRO D139402Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation3 deaths171 reports
- ThermoCool SmartTouch D133601Cardiac ablation percutaneous catheter10 deaths162 reports
- PREFACE 301803MINTRODUCER, CATHETER1 death152 reports
- OCTARAY Mapping Catheter D160903Catheter, intracardiac mapping, high-density array146 reports
- QDOT MICRO D139504catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- PENTARAY NAV D128210CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls31 reports
- ThermoCool SmartTouch D132704Cardiac ablation percutaneous catheter7 deaths121 reports
- PENTARAY NAV D128207CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls15 reports
- QDOT MICRO D139401catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- OCTARAY Mapping Catheter D160901Catheter, intracardiac mapping, high-density array1 death113 reports
- NaviStar ThermoCool NI75TCDHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- DECANAV R7F282CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- SOUNDSTAR 10439236Catheter, ultrasound, intravascular4 deaths107 reports
- PENTARAY NAV D128201CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls6 reports
- EZ Steer NAV BN7TCDF4LCardiac ablation percutaneous catheter2 deaths105 reports
- NaviStar RMT ThermoCool NR7TCSIYcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- PENTARAY NAV D128203CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls1 report
- PENTARAY NAV D128205CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls1 death1 report
- PENTARAY NAV D128202CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls0 reports
- PENTARAY NAV D128204CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls0 reports
- PENTARAY NAV D128206CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls0 reports
- PENTARAY NAV D128209CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY2 recalls0 reports
- SOUNDSTAR 10439011Catheter, ultrasound, intravascular2 deaths90 reports
- LASSO NAV D134301CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- QDOT MICRO D139501Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 deaths73 reports
- THERMOCOOL SMARTTOUCH SF D134703Cardiac ablation percutaneous catheter3 deaths72 reports
- OCTARAY Mapping Catheter D160906Catheter, intracardiac mapping, high-density array2 deaths61 reports
- CARTO VIZIGO D138505Introducer, catheter61 reports
- ThermoCool SmartTouch D132701Cardiac ablation percutaneous catheter51 reports
- PENTARAY NAV D128212CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY1 recall0 reports
- OCTARAY Mapping Catheter D160904Catheter, intracardiac mapping, high-density array48 reports
- nGEN Generator D138402Cardiac ablation percutaneous catheter2 deaths46 reports
- NaviStar NS7TCDL174HSCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death44 reports
- OPTRELL Mapping Catheter with TRUEref Technology D142901Catheter, intracardiac mapping, high-density array41 reports
- PREFACE 301803MSINTRODUCER, CATHETER38 reports
- NaviStar ThermoCool NI75TCFHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter36 reports
- EZ Steer ThermoCool NAV BNI75TCDFHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths35 reports
- SOUNDSTAR 10439072Catheter, ultrasound, intravascular4 deaths29 reports
- NaviStar NS7TCFL174HSCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death27 reports
- OPTRELL D140901CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING27 reports
- Lasso NAV D134302CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING26 reports
- EZ Steer NAV BN7TCFJ4LCardiac ablation percutaneous catheter24 reports
- Lassostar NAV D140401CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING24 reports
- OCTARAY Mapping Catheter D160902Catheter, intracardiac mapping, high-density array24 reports
- ThermoCool SmartTouch D133603Cardiac ablation percutaneous catheter1 death23 reports
- ThermoCool SF NAV BNI35DFHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death22 reports
- Webster CS BD710DF282CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING21 reports
- SOUNDSTAR 10438577Catheter, ultrasound, intravascular1 death21 reports
- THERMOCOOL SMARTTOUCH SF D134802Cardiac ablation percutaneous catheter20 reports
- ThermoCool SF NAV BNI35DFCTcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter3 deaths18 reports
- TRUPULSE™ Generator D141702Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation18 reports
- NuVision ICE Catheter FG10593Catheter, Ultrasound, Intravascular1 death17 reports
- Webster CS BD710FJ282CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths17 reports
- EZ Steer NAV DS BN7TCDF8Lcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter17 reports
- nGEN Pump D139702Cardiac ablation percutaneous catheter17 reports
- Webster CS BD710DF282RTSCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING16 reports
- Reference Patch CARTO 3 CREFP6CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING16 reports
- EZ Steer BD7TCDF4LCardiac ablation percutaneous catheter15 reports
- EZ Steer NAV DS BN7TCFJ8Lcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter15 reports
- OCTARAY Mapping Catheter D160905Catheter, intracardiac mapping, high-density array15 reports
- EZ Steer DS BD7TCFJ8LCardiac ablation percutaneous catheter14 reports
- WEBSTER CS D135304CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING13 reports
- ThermoCool SF NAV BNI35BDHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter12 reports
- Webster CS BD710FJ282RTSCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death11 reports
- ThermoCool SF NAV BNI35FJCTcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death11 reports
- NaviStar ThermoCool NI75TCBHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter11 reports
- Lasso Nav D134901CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING11 reports
- WEBSTER CS D135303CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths11 reports
- SOUNDSTAR SNDSTR10Catheter, ultrasound, intravascular9 reports
- ThermoCool SF BDI35DFRTcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death9 reports
- ThermoCool SF NAV D131503Cardiac ablation percutaneous catheter9 reports
- WEBSTER D728260RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING8 reports
- Lassostar NAV D140402CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING8 reports
- ThermoCool SmartTouch D132702Cardiac ablation percutaneous catheter7 reports
- NaviStar ThermoCool NI75TCJHcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- NaviStar DS NS7TCD8L174HScatheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- NaviStar DS NS7TCF8L174HScatheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- Noga-Star 120708SCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death6 reports
- ThermoCool SF NAV BNI35BDCTcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death6 reports
- ThermoCool SF NAV D131802Cardiac ablation percutaneous catheter6 reports
- Celsius FLTR D135502catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- QDOT MICRO D139403Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 death6 reports
- Celsius ThermoCool DI7TCFLRTcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports