Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
FDA product code QZI · Class 3 · 24 devices · 3,188 reports · 72 deaths reported · 3 devices named in recalls
- FARAWAVE™ M004PF41M401Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall39 deaths1,515 reports
- PulseSelect™ PSCC100Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation3 deaths496 reports
- FARAWAVE™ NAV M004PF41M411Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths417 reports
- VARIPULSE™ Bi-Directional Catheter D141201Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall3 deaths273 reports
- FARAWAVE™ M004PF41M431Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths272 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall15 reports
- FARAWAVE™ M004PF41M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths57 reports
- Volt™ PFA Sensor Enabled™ A-VOLT-01St. Jude Medical, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths38 reports
- Current™ PFA-GEN-01St. Jude Medical, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation22 reports
- TRUPULSE™ Generator D141702Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation18 reports
- FARAWAVE™ NAV M004PF41M412Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation16 reports
- FARASTAR™ M004PF41M434Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation13 reports
- FARASTAR™ M004PF61M401Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation10 reports
- FARASTAR™ M004PF61M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation6 reports
- FARASTAR™ M004PF41M444Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation5 reports
- FARAPOINT™ M004PF81M110Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 death3 reports
- FARASTAR™ M004PF61M415Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 reports
- FARAWAVE™ M004PF41M432Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 reports
- FARASTAR™ M004PF61M601Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 reports
- HexaGen™ RF Generator AFR-00004Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 reports
- PulseSelect™ PSG100Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 report
- HexaPulse™ PF Generator AFR-00008Medtronic, Inc. · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 report
- Sterile Interface Cable D133701Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 report
- Dual Energy Thermocool Smarttouch SF Catheter D134814Biosense Webster Inc · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 report