catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
FDA product code OAD · Class 3 · 96 devices · 2,636 reports · 86 deaths reported · 2 devices named in recalls
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 reports
- FlexAbility™ A-FASE-DFSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 deaths65 reports
- Sphere-9™ AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall7 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620N40Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter48 reports
- MetriQ™ Irrigation Tubing Set M0041170Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter40 reports
- IntellaNav™ Open-Irrigated M004R96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter39 reports
- NaviStar ThermoCool NI75TCFHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter36 reports
- EZ Steer ThermoCool NAV BNI75TCDFHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths35 reports
- FlexAbility™ A-FASE-DSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths33 reports
- FlexAbility™ A701125St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths29 reports
- FlexAbility™ A-FASE-FJSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death29 reports
- Maestro Foot Switch M004218500Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter23 reports
- ThermoCool SF NAV BNI35DFHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death22 reports
- FlexAbility™ A-FASE-FSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter20 reports
- FlexAbility™ A701157St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter18 reports
- IntellaTip MiFi™ XP M004PM4500K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter18 reports
- ThermoCool SF NAV BNI35DFCTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter3 deaths18 reports
- Cool Point™ IBI-89003Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter17 reports
- EZ Steer NAV DS BN7TCDF8LBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter17 reports
- IntellaTip MiFi™ Open-Irrigated M004PM96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter15 reports
- EZ Steer NAV DS BN7TCFJ8LBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter15 reports
- IntellaNav™ Open-Irrigated M004R9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths14 reports
- FlexAbility™ A701158St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death12 reports
- ThermoCool SF NAV BNI35BDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter12 reports
- ThermoCool SF NAV BNI35FJCTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death11 reports
- NaviStar ThermoCool NI75TCBHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter11 reports
- Maestro 4000™ Controller M0044000R0Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter10 reports
- IntellaTip MiFi™ XP M004PM45000Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 reports
- ThermoCool SF BDI35DFRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death9 reports
- Safire™ TX 402840Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter8 reports
- Blazer® II XP M0044500THK20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter8 reports
- IntellaTip MiFi™ XP M004PM4790K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter8 reports
- Blazer Prime® XP M004P4500THK20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- MetriQ™ Pump M00441000Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- IntellaNav MiFi™ XP M004MR4500K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- IntellaNav™ Open-Irrigated M004R9620N40Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- NaviStar ThermoCool NI75TCJHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- NaviStar DS NS7TCD8L174HSBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- NaviStar DS NS7TCF8L174HSBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- ThermoCool SF NAV BNI35BDCTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death6 reports
- Celsius FLTR D135502Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter6 reports
- Ampere™ H700494St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- FlexAbility™ A701128St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths5 reports
- Maestro 3000™ M00421000TCR0Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- IntellaTip MiFi™ XP M004PM47900Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- IntellaNav MiFi™ XP M004MR45000Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- Celsius ThermoCool DI7TCFLRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- ThermoCool SF BDI35FJRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- EZ Steer ThermoCool BDI75TCFJRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- ThermoCool SF NAV BNI35BBHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- ThermoCool SF NAV BNI35DDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter5 reports
- EZ Steer ThermoCool NAV BNI75TCFJHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death5 reports
- MetriQ™ Pump M0044100R0Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 reports
- NaviStar ThermoCool NI75TCCHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 reports
- FlexAbility™ A-FASE-DDSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter3 reports
- IntellaTip MiFi™ Open-Irrigated M004PM9620N40Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter3 reports
- IntellaNav MiFi™ XP M004MR4500N40Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter3 reports
- EZ Steer ThermoCool BDI75TCDFRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter3 reports
- ThermoCool SF NAV BNI35BFHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death3 reports
- INTELLAGEN™ Tubing Set 20626Stockert GmbH · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter2 reports
- FlexAbility™ A701124St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- FlexAbility™ A-FASE-JJSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- Sensor Enabled™ CableSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- Blazer® II XP M0044790THK20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- Blazer Prime® XP M004P4790THN40Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- Maestro 4000™ Remote Control M00440200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- Blazer® Open-Irrigated M00496200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- Blazer® Open-Irrigated M0049620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- RHYTHMIA HDx™ M004RA6201US0Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- NaviStar DS NS7TCJ8L174HSBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death2 reports
- ThermoCool SF BDI35DDRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death2 reports
- EZ Steer ThermoCool NAV BNI75TCDDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 reports
- INTELLAGEN™ Irrigation Pump Kit 20402Stockert GmbH · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter1 report
- Safire™ TX 402841Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- Therapy™ IBI-83371Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- NA IBI-85786Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- FlexAbility™ A701159St. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- FlexAbility™ A-FASE-FFSt. Jude Medical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 death1 report
- Blazer® II XP M0044500TH0Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- IntellaTip MiFi™ Open-Irrigated M004PM9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- MetriQ™ Pump M0044100H0Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- IntellaNav™ XP M004R4500THK20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- Celsius DS D7TCF8L162RTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- EZ Steer NAV DS BN7TCDD8LBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- ThermoCool SF NAV BNI35BFCTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- ThermoCool SF NAV BNI35FFCTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- ThermoCool SF NAV BNI35JJCTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- Celsius RMT ThermoCool CR7TCSIRTBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- QDOT MICRO D139502Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report