Cases of AEF, including death associated with the use of percutaneous RF ablation catheters for the treatment of AF, have been reported in Canada and internationally. Products affected Manufacturer/Canadian distributor Device Name CF-sensing Biotronik ALCATH/ALCATH FLUX MAPPING AND ABLATION CATHETERS No Boston Scientific STINGER ABLATION CATHETER No CHILL II COOLED ABLATION CATHETER No BLAZER OPEN-IRRIGATED ABLATION CATHETER No INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER No INTELLANAV OPEN-IRRIGATED ABLATION CATHETER No BLAZER CARDIAC ABLATION CATHETERS No BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS No INTELLANAV TEMPERATURE ABLATION CATHETERS No Johnson & Johnson Medical Products THERMOCOOL SMARTTOUCH DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER Yes NAVI-STAR DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER No NON-NAVIGATIONAL CATHETERS No NAVIGATIONAL BI-DIRECTIONAL CATHETERS No RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER No DIAGNOSTIC/ ABLATION ELECTROPHYSIOLOGY CATHETERS No CELSIUS RMT DIAGNOSTIC/ ABLATION STEERABLE TIP CATHETER No Abbott Laboratories TACTICATH QUARTZ Yes SAFIRE BIDIRECTIONAL ABLATION CATHETER No FLEXABILITY ABLATION CATHETER, SENSOR ENABLED No LIVEWIRE TC(TM) ABLATION CATHETERS No THERAPY COOL PATH ABLATION CATHETER No SAFIRE DUO ABLATION CATHETER MEDIGUIDE ENABLED No COOLPATH DUO ABLATION CATHETER MEDIGUIDE ENABLED No SAFIRE BLU No THERAPY ABLATION CATHETERS No FLEXABILITY ABLATION CATHETER No THERAPY COOL FLEX No Medtronic PULMONARY VEIN ABLATION CATHETER GOLD No RF ENHANCR II STEERABLE ELECTRODE CATHETER FOR INTRACARDIAC ABLATION No RF MARINR STEERABLE ELECTRODE CATHETER FOR INTRACARDIAC ABLATION No RF CONTACTR STEERABLE ELECTRODE CATHETER FOR INTRACARDIAC ABLATION No
RecallTracker