THERMOCOOL SMARTTOUCH SF D134801Recalls & reported problems

Summary

The FDA's MAUDE database contains 608 adverse event reports that list this exact device (DI 10846835010145), received between Nov 9, 2016 and May 21, 2026 — classified as 15 deaths, 463 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (364 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 608 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL SMARTTOUCH SF (STSF) AND THE PATIENT EXPERIENCED CEREBRAL INFARCTION THAT REQUIRED PROLONGED HOSPITALIZATION. APPROXIMATELY ONE HOUR AFTER COMPLETION OF THE PROCEDURE PATIENT DEVELOPED A DISTURBANCE OF CONSCIOUSNESS AND WAS DIAGNOSED WITH A CEREBRAL INFARCTION CAUSED BY THROMBUS. TO NOTE, IN THIS PROCEDURE, PULMONARY VEIN ISOLATION AND POSTERIOR WALL ISOLATION USING PULSE FIELD ABLATION WITH PULSE SELECT WERE PERFORMED, ALONG WITH CAVOTRICUSPID ISTHMUS (CTI) LINE ABLATION USING A STSF. CONTACT FORCE MONITORING METHODS WERE: REAL TIME GRAPH, DASHBOARD, VECTOR, VISITAG. VISITAG COLORING SETTING WAS TAG INDEX. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO, OR DURING USE OF THE PRODUCT.

  Patient problems: Stroke/CVA

  MAUDE report 25249708 ↗
• InjuryMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED DRAINAGE. THE REPORT INDICATED THAT AFTER 2 HOURS OF STARTING THE PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT'S BLOOD PRESSURE DECREASED AND CARDIAC TAMPONADE WAS NOTED. DRAINAGE WAS PERFORMED AND THE PATIENT'S BLOOD PRESSURE STABILIZED. THE BLOOD WAS DESCRIBED AS VENOUS-LIKE IN COLOR. A DECREASE IN BLOOD PRESSURE HAD BEEN RECORDED IMMEDIATELY AFTER THE START OF PVI, BUT IT WAS UNKNOWN WHETHER THE BLOOD PRESSURE DECREASE WAS DUE TO CARDIAC TAMPONADE. THE PHYSICIAN COMMENTED THAT WHILE ABLATING THE LEFT ATRIUM (LA) ROOF WITH THE THERMOCOOL SMARTTOUCH SF CATHETER THERE HAD BEEN A TIMING WHEN CONTACT FORCE BECAME HIGH DUE TO RESPIRATION, AND THAT THIS COULD NOT BE EXCLUDED AS A POSSIBLE CAUSE; HOWEVER, THE CAUSE WAS UNKNOWN. THE PATIENT WAS ABLE TO CONVERSE. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS NON-SERIOUS (MODERATE/MINOR). NO PROLONGATION OF HOSPITAL STAY WAS NOTED. THE COLORING SETTING OF VISITAG WAS TAG INDEX. THE ADDITIONAL FILTER

  Patient problems: Cardiac Tamponade

  MAUDE report 24576074 ↗
• InjuryFeb 23, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC BLOCK/VENTRICULAR FIBRILLATION/CARDIAC ARREST THAT REQUIRED DIRECT CURRENT (DC) SHOCK AND CARDIAC MASSAGE. FIRST IT WAS REPORTED THAT THE TAG SET UP SCREEN DISAPPEARED. THE ACQUISITION BUTTON WOULD NOT BECOME ACTIVE UNLESS THE POTENTIAL WAS CLICKED. THE TIMING WAS WHEN "RIPPLE" WAS STARTED/WHEN OBTAINING "PASO PM" WITH OPTRELL. THESE ISSUES WITH THE OPTRELL AND CARTO 3 SYSTEM ARE NOT CONSIDERED MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. THEN IT WAS REPORTED THAT PATIENT HAD CARDIAC BLOCK. VENTRICULAR TACHYCARDIA (VT) WAS INDUCED AFTER POST-ABLATION INDUCTION AND IT PROGRESSED TO VENTRICULAR FIBRILLATION (VF). DC SHOCK WAS PERFORMED, BUT THE PATIENT WENT INTO CARDIOPULMONARY ARREST (CPA). REPEATED CARDIAC MASSAGE WAS ADMINISTERED, AND SPONTANEOUS CARDIAC ACTIVITY WAS EVENTUALLY RESTORED. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT IMPROVED. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT IS THAT

  Patient problems: Cardiac Arrest; Heart Block; Ventricular Fibrillation

  MAUDE report 24424657 ↗
• InjuryJan 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH PERICARDIAL DRAINAGE WHICH REQUIRED PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT DURING RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION, CARDIAC TAMPONADE OCCURRED. DURING RVOT MAPPING, BUMP WAS CONFIRMED. SUBSEQUENTLY, WHILE PERFORMING PACE MAPPING, A DECREASE IN PATIENT¿S BLOOD PRESSURE WAS OBSERVED. DURING THE PROCEDURE, CONTACT FORCE (CF) INCREASED TO THE HIGH RANGE OF 20¿50G, AND ZEROING WAS RE-PERFORMED. THE PROCEDURE WAS TERMINATED, AND PERICARDIAL DRAINAGE WAS PERFORMED. APPROXIMATELY 500 ML OF PERICARDIAL FLUID WAS DRAINED, AND BLOOD TRANSFUSION WAS PERFORMED. THE PHYSICIAN ASSESSMENT OF THE HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). EXTENDED HOSPITALIZATION WAS NOTED. THE METHODS OF CF MONITORING WERE REAL TIME GRAPH, DASHBOARD, AND VISITAG. THE COLORING SETTING FOR VISITAG WAS TAG INDEX. THE VISITAG ADDITIONAL FILTER WAS IMPEDANCE DROP. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. THE CONTACT FORCE ISSUE IS NOT MDR REPORTABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 24065028 ↗
• MalfunctionDec 17, 2025Coagulation in Device or Device Ingredient; Obstruction of Flow; Coagulation in Device or Device Ingredient; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF. AFTER CONDUCTING PULMONARY VEIN ISOLATION (PVI), THE ABLATION CATHETER WAS TAKEN OUT OF THE PATIENT'S BODY, AND UPON FLUSHING, NO WATER CAME OUT FROM THE ENTIRE CATHETER. ALSO, THERE WAS SOMETHING RESEMBLING A THROMBUS THAT WAS ADHERED TO THE CATHETER. THE TIP OF THE CATHETER WAS WIPED MANUALLY, BUT THERE WAS NO CHANGE IN IRRIGATION. THEREFORE, THE THERMOCOOL SMARTTOUCH SF CATHETER WAS REPLACED WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE THROMBUS WAS LOCATED ON THE TIP ELECTRODE. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES. NO IRRIGATION SOLUTION CAME OUT FROM THE ENTIRE CATHETER DURING FLUSHING OUTSIDE THE PATIENT. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. POWER CONTROL MODE WAS USED ON THE GENERATOR: TARGET TEMPERATURE: 55, TEMPERATURE CUT OFF: 65. IMPEDANCE CUT OFF: MAX 200O, MIN 75 O, DELTA 100 O. POWER: 40W. THE ACTIVATED CLOTTING TIME (ACT) WAS KEPT 350 SECONDS OVER. THE DURATION OF ABLATION USED WAS GREATER THAN 60 SECONDS, B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834966 ↗
• InjuryDec 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CEREBROVASCULAR ACCIDENT WHICH REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT EXPERIENCED CEREBRAL INFARCTION AND DETAILS WERE UNKNOWN. THE CEREBRAL INFARCTION DEVELOPED ON POSTOPERATIVE DAY 2 (ON (B)(6) 2025) AND THE PATIENT WAS BEING FOLLOWED UP. FINGER PARALYSIS PERSISTS AT PRESENT. THE PHYSICIAN¿S ASSESSMENT REGARDING HEALTH HAZARD WAS NOT-SERIOUS (MODERATE/MILD). EXTENDED HOSPITALIZATION WAS NOTED. CF MONITORING METHODS WERE DASHBOARD, VECTOR, AND VISITAG. THE VISITAG COLORING SETTING WAS TAG INDEX. THE PHYSICIAN¿S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT IT WAS THIS PROCEDURE, RFA (CTI) WAS PERFORMED WITH THERMOCOOL SMARTTOUCH SF CATHETER, AND PFA (PVI, BOX) WAS PERFORMED WITH PULSE SELECT (MEDTRONIC). THE PHYSICIAN HAS NOT IDENTIFIED A DIRECT CAUSE BUT SUSPECTS IT MAY BE RELATED TO PFA. SINCE THE SHEATH WAS REPLACED, AIR EMBOLISM IS ALSO BEING CONSIDERED. NO ABNORMALITIES OBSERVED PRIOR/DURING PRODUCT USE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-NOV-2025. THE PHYSICIAN REPORTED THAT THE PATIENT WHO UNDERWENT

  Patient problems: Stroke/CVA

  MAUDE report 23798711 ↗
• MalfunctionDec 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND AFTER PERFORMING PULMONARY VEIN ISOLATION AND CAVOTRICUSPID ISTHMAS ABLATION (3 HOURS AFTER THE PATIENT ENTERED THE ROOM) THE MEDICAL TEAM BECAME UNABLE TO FLUSH THE CATHETER. THIS SPECIFICALLY OCCURRED AT THE TIME OF ABLATING THE GAP AREA OF THE CAVOTRICUSPID ISTHMAS. THERE WERE NO ERROR CODES PRECEDING THE ISSUE. CHAR WAS SUSPECTED BUT NO CHAR WAS VISUALLY CONFIRMED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER WITH ANOTHER ONE. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771580 ↗
• DeathNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CARDIAC TAMPONADE. THE PATIENT PASSED AWAY UNDER CARE. PHYSICIAN'S JUDGMENT ON HEALTH HAZARD WAS SERIOUS. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE CARDIAC TAMPONADE OCCURRED AT SOME POINT DURING THE MANIPULATION OF THE THERMOCOOL SMARTTOUCH SF CATHETER. NO EXTENDED HOSPITALIZATION. THE SEPTAL PUNCTURE WAS PERFORMED WITH RF NEEDLE. THE VISITAG COLORING SETTING WAS TAG INDEX. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. LABORATORY TESTS AND RESULTS: PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION WAS COMPLETE. THE ATRIAL TACHYCARDIA WAS SUPPRESSED, BUT STILL INDUCIBLE. MEDICAL HISTORY/TREATMENT HISTORY/OTHER DISEASES CURRENTLY BEING TREATED: THE PATIENT HAD A PACEMAKER IMPLANTED. CAVOTRICUSPID ISTHMUS ABLATION WAS PERFORMED DURING THE INITIAL ABLATION. THERE WERE NO ERRORS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 23511499 ↗
• InjuryOct 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) FOR PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CARDIAC TAMPONADE AND ADMINISTERED NORADRENALIN AND PROTAMINE. REQUIRED PROLONGED HOSPITALIZATION. IN THE PROCEDURE, AFTER PERFORMING APPROXIMATELY FIVE ABLATIONS JUST BELOW THE PULMONARY VALVE, A DECREASE IN BLOOD PRESSURE WAS OBSERVED WHILE ATTEMPTING TO MOVE THE THERMOCOOL SMARTTOUCH SF CATHETER OVER THE PULMONARY VALVE. ECHOCARDIOGRAPHY CONFIRMED EFFUSION. THE EFFUSION WAS MINIMAL. THE SEDATION WAS DISCONTINUED AND AFTER ADMINISTERING NORADRENALIN AND PROTAMINE, THE PATIENT'S BLOOD PRESSURE RECOVERED WITHIN ABOUT 30 MINUTES. NO DRAINAGE WAS PERFORMED. THE PATIENT RETURNED TO THE ROOM. TIMING WAS APPROXIMATELY 2 HOURS FROM THE START OF THE PROCEDURE. ATRIAL SEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS PERFORMED BEFORE PERICARDIAL EFFUSION WAS IDENTIFIED. STEAM POP WAS NOT OBSERVED. IRRIGATION CATHETER¿S FLOW RATE SETTING WAS DEFAULT. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS NON-SERIOUS (MODERATE/MINOR). PROLONGATION OF HOSPITAL STAY WAS CONFIRMED. THE CONTACT FORCE (CF

  Patient problems: Cardiac Tamponade

  MAUDE report 23354550 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED DRAINAGE AND MEDICATION. DURING CAVO-TRICUSPID ISTHMUS RADIOFREQUENCY ABLATION, A CARDIAC TAMPONADE OCCURRED. THE PATIENT¿S BLOOD PRESSURE DROPPED TO THE 60S, AND IMMEDIATE DRAINAGE WAS PERFORMED, STABILIZING THE BLOOD PRESSURE. THE PATIENT WAS MANAGED WITH MEDICATION. THE PATIENT¿S CONDITION IMPROVED THE NEXT DAY. THE PROGRESS WAS IMPROVED. THE COLORING SETTING OF VISITAG WAS TAG INDEX, AND THE CONTACT FORCE MONITORING METHOD WAS FORCE OVER TIME. NO ABNORMALITIES WERE OBSERVED PRIOR/DURING USE OF THE PRODUCT. CAUSAL RELATIONSHIP WITH THE PRODUCT WAS UNKNOWN. THE PHYSICIAN'S JUDGMENT ON HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). THE PHYSICIAN'S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT IT WAS UNKNOWN WHEN THE EVENT OCCURRED FROM THE TIME OF THE CATHETER INSERTION TO THE CORONARY SINUS (CS) TO THE TIME OF ABLATION BY THE CATHETER. THEREFORE, IT¿S UNKNOWN WHETHER THE CAUSE WAS DURING CS CATHETER INSERTION OR DURING ABLATION WITH ABLATION CATHETER. THE CS CATHETER INFORMAT

  Patient problems: Cardiac Tamponade

  MAUDE report 23304341 ↗
• InjurySep 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED HOSPITALIZATION. CARDIAC TAMPONADE OCCURRED THIRTY MINUTES AFTER THE ABLATION. WHILE CREATING THE POST-VOLTAGE MAP WITH THE PENTARAY NAV SH, BLOOD PRESSURE DECREASED. PATIENT REQUIRED EXTENDED HOSPITALIZATION. ADDITIONAL INTERVENTION DETAILS ARE UNKNOWN. RADIOFREQUENCY (RA) ABLATION HAD ALREADY BEEN PERFORMED BEFORE BLOOD PRESSURE DECREASE WAS CONFIRMED; THE EVENT OCCURRED MAPPING PHASE AFTER ABLATION WAS PERFORMED WITH BWI PRODUCTS. NO STEAM POP WAS CONFIRMED. THE IRRIGATION CATHETER¿S FLOW RATE SETTING WAS 8 ML/MIN OR 15 ML/MIN. ONE CATHETER EXCHANGE OCCURRED DURING THE PROCEDURE FOR EACH. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH RF NEEDLE. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 23042472 ↗
• MalfunctionSep 4, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE SECOND ELECTRODE AND THE PEBAX WERE DISLODGED FROM ITS ORIGINAL LOCATION. IN ADDITION THE ELECTRODE WAS FOUND LIFTED, LEAVING ELECTRICAL COMPONENTS EXPOSED. DURING THE PROCEDURE, THE POTENTIAL OF ONLY THE 1-2 ELECTRODE SUDDENLY DISAPPEARED. THIS OCCURRED APPROXIMATELY 2 HOURS AFTER INSERTION INTO THE PATIENT'S BODY WHEN THE CATHETER WAS EXCHANGED FOR THE SHEATH. THE ISSUE WAS NOT RESOLVED BY RECONNECTING AND REPLACING THE CABLE. THE ISSUE WAS RESOLVED BY REPLACING THE SMART TOUCH SF CATHETER WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968481 ↗
• InjurySep 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED DURING AN ATRIAL TACHYCARDIA CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT EXPERIENCED CARDIAC BLOCK TREATED WITH TEMPORARY PACEMAKER IMPLANTATION. IN THE ATRIAL TACHYCARDIA PROCEDURE, MAPPING REVEALED FOCAL AT AROUND THE 2 O'CLOCK POSITION OF THE TRICUSPID ANNULUS, AND A:V (ATRIOVENTRICULAR) CONDUCTION WAS 1:1. HOWEVER, WHEN THE EARLIEST EXCITATION SITE WAS ABLATED, AV CONDUCTION CHANGED TO 2:1 IN ABOUT 5 SECONDS, AND THE ABLATION WAS STOPPED. SUBSEQUENTLY, THE AV CONDUCTION RATIO REMAINED UNCHANGED WITH CARDIAC BLOCK, AND THE PATIENT LEFT THE ROOM WITH A TEMPORARY PACEMAKER IMPLANTATION. THE PHYSICIAN¿S ASSESSMENT ON HEALTH HAZARD WAS SERIOUS. EXTENSION OF HOSPITALIZATION NOTE. THE METHOD OF CF (CONTACT FORCE) MONITORING WAS REAL-TIME GRAPH, DASHBOARD, AND VECTOR. THE TAG COLORING SETTING IN VISITAG WAS TAG INDEX. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT RELATED ISSUES. THE INTERVENTION PROVIDED WAS A TEMPORARY PACEMAKER WAS IMPLANTED. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE AV CONDUCTION HAS RECOVERED

  Patient problems: Heart Block

  MAUDE report 22939724 ↗
• InjuryAug 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED SINUS ARREST DUE TO COUGHING REQUIRING TEMPORARY PACEMAKER AND PROLONGED HOSPITALIZATION. DURING THE SUPERIOR VENA CAVA (SVC) ISOLATION, THE THERMOCOOL SMARTTOUCH SF WAS MOVED NEAR THE SINUS NODE DUE TO THE PATIENT'S RESPIRATION (COUGHING), RESULTING IN SINUS ARREST/CARDIAC BLOCK. A TEMPORARY PACEMAKER WAS PLACED, AND THE PATIENT LEFT THE ROOM. THE CATHETER HAD BEEN IN USE SINCE THE SVC ISOLATION, AND THE EVENT OCCURRED APPROXIMATELY TWENTY MINUTES AFTER THE START OF ITS USE. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS THAT IT WAS SERIOUS AND REQUIRED EXTENDED HOSPITALIZATION. CONTACT FORCE (CF) MONITORING METHODS WERE REAL TIME GRAPH, DASHBOARD, AND VECTOR. COLORING SETTING FOR VISITAG WAS TAG INDEX. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE ISSUE WAS MOST LIKELY CAUSED BY THE CATHETER MOVING DURING ABLATION DUE TO THE PATIENT'S BREATH. THE OUTCOME OF THE ADVERSE EVENT IMPROVED, AND THE SINUS RHYTHM R

  Patient problems: Heart Block

  MAUDE report 22920095 ↗
• InjuryAug 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) BLOCK WHICH REQUIRED A PACEMAKER IMPLANTATION. DURING PVC PROCEDURE, ABLATION WAS PERFORMED TARGETING AT 9 O'CLOCK POSITION OF THE MITRAL VALVE. THE ABLATION WAS CONDUCTED AT 20W TO 30W WHILE CONFIRMING HIS POTENTIAL FROM THE HIS BODY SURFACE SIDE. ALTHOUGH THE ABLATION WAS BEING PROCEEDED CAREFULLY, AV BLOCK OCCURRED AT THE 30TH ABLATION. THE PHYSICIAN'S ASSESSMENT OF HEALTH HAZARD WAS NON-SEVERE (MODERATE/MILD). NO EXTENSION OF HOSPITALIZATION. THE PHYSICIAN'S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THIS EVENT WAS A SHOCK (TO THE PHYSICIAN) BECAUSE THE ABLATION PROCEEDED WITH CAUTION AS THE LOCATION WAS WITH RISKS. THE CATHETER POSITION AND CONTACT FORCE WERE NOT BAD, SO THE PHYSICIAN DID NOT THINK THERE WAS ANY PROBLEM WITH THE PRODUCT. MORE CAREFUL OBSERVATION WAS NEEDED. VISITAG COLOR SETTING WAS TAG INDEX. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ONE CATHETER WAS USED FOR EACH CATHETER EXCHANGE DURING THE PROCEDURE. THE ENERG

  Patient problems: Heart Block

  MAUDE report 22690456 ↗
• MalfunctionJul 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE IRRIGATION ISSUE (USED ON PATIENT) WAS OBSERVED. DURING THE LEFT PULMONARY VEIN (LPV) ABLATION, THE IRRIGATION HOLE WAS CLOGGED PREVENTING FLUSHING. THE ISSUE WAS RESOLVED BY REPLACING THE THERMOCOOL SMARTTOUCH SF CATHETER TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 02-JUL-2025. THE CATHETER WAS THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. THE ISSUE WAS NOTED AFTER THE THERMOCOOL SMARTTOUCH SF CATHETER WAS USED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 23-JUL-2025. NO ERROR WAS NOTED FROM THE IRRIGATION PUMP. THE CATHETER WAS FOUND NOT BEING IRRIGATED WHEN THE PHYSICIAN CHECKED THE CATHETER TIP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584075 ↗
• MalfunctionJul 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) AND IRRIGATION PORT BLOCKAGE WAS OBSERVED. IT WAS REPORTED THAT SYMPTOMS SIMILAR TO IRRIGATION PORT BLOCKAGE WERE OBSERVED. NO ERROR CODES WERE PRESENT. IT OCCURRED APPROXIMATELY FOUR (4) HOURS AFTER THE STSF WAS USED ON THE PATIENT. WHEN THE CATHETER WAS OUTSIDE OF THE PATIENT¿S BODY, IT WAS FLUSHED AND PARTIAL IRRIGATION WAS OBSERVED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573221 ↗
• MalfunctionJul 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND AN IRRIGATION ISSUE WAS DISCOVERED. THREE (3) HOURS AFTER CATHETER USE, AFTER REMOVING THE ABLATION CATHETER FROM THE PATIENT'S BODY, IRRIGATION WAS STOPPED ONCE. WHEN IT WAS RESUMED, THERE WAS NO IRRIGATION FROM SEVERAL HOLES. NO ERROR WAS NOTED FROM THE SMARTABLATE IRRIGATION PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE ISSUE WAS DISCOVERED DURING FLUSHING BEFORE RETURNING THE CATHETER INTO THE PATIENT'S BODY. THE IRRIGATION ISSUE WAS VISUALLY CONFIRMED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530579 ↗
• InjuryJul 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED AFTER CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED DECREASE VITAL SIGNS/CARDIAC TAMPONADE TREATED WITH NOREPINEPHRINE AND DRAINAGE. AFTER THE PROCEDURE, A DECREASE IN BLOOD PRESSURE/CARDIAC TAMPONADE WAS OBSERVED AND THEREFORE ECHOCARDIOGRAPHY WAS PERFORMED. NOREPINEPHRINE WAS ADMINISTERED, WHICH LED TO AN INCREASE IN BLOOD PRESSURE. DRAINAGE WAS THEN PERFORMED. NO EXTENDED HOSPITALIZATION. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE ENERGY SOURCE USED WHEN THE ADVERSE EVENT OCCURRED WAS RADIO FREQUENCY (RF). PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. NO PFA ENERGY SOURCE WAS USED. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 22501353 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) CATHETER, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. DURING ABLATION, THE PHYSICIAN MENTIONED THAT A STEAM POP MIGHT HAVE OCCURRED DURING THE ABLATION OF THE INFERIOR PART OF THE LEFT ATRIAL CORE. IMMEDIATELY AFTERWARD, THE CONDITION OF THE PERICARDIAL EFFUSION WAS CHECKED WITH AN ULTRASOUND IMAGE, BUT NOTHING WAS NOTED. AFTER A WHILE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND UPON CHECKING THE ULTRASOUND IMAGE, THERE WAS PERICARDIAL EFFUSION/CARDIAC TAMPONADE. SUBSEQUENTLY, DRAINAGE WAS CONDUCTED. THERE WERE NO ERRORS OR MALFUNCTIONS WITH THE STSF CATHETER OR NGEN BEFORE AND DURING THE ABLATION. THERE WERE NO MALFUNCTIONS WITH THE ELECTROPHYSIOLOGY (EP) PRODUCTS. ABLATION WAS PERFORMED PRIOR TO THE CARDIAC TAMPONADE BEING IDENTIFIED. THERE WAS NO EXTENDED HOSPITALIZATION. THE IRRIGATION CATHETER¿S FLOW RATE SETTING WAS 15ML/MIN. CONTACT FORCE (CF) MONITORING METHODS WERE REAL TIME GRAPH, DASHBOARD, VECTOR, VISITAG, AND VISITAG COLORING SETTING WAS TAG INDEX. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT A STE

  Patient problems: Cardiac Tamponade

  MAUDE report 22459602 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED DRAINAGE. THE REPORT INDICATED THAT PRE-OP, A THERMOCOOL SMARTTOUCH SF CATHETER HAD ERROR 105 OCCURRED DURING CONNECTING THE CATHETER AND CABLE. THE ISSUE WAS NOT RESOLVED BY REPLACING THE CABLE. THE ISSUE WAS RESOLVED BY REPLACING THE THERMOCOOL SMARTTOUCH SF CATHETER WITH ANOTHER NEW ONE (THERMOCOOL SMARTTOUCH SF CATHETER / LOT #: 31528832L). DURING THE PROCEDURE, A CARDIAC TAMPONADE OCCURRED, AND DRAINAGE WAS PERFORMED. THE VITAL SIGNS STABILIZED. PUNCTURE WAS PERFORMED WITH A RF NEEDLE. NO EXTENDED HOSPITALIZATION. AFTER THE SOUNDSTAR ECO CATHETER WAS BEING INSERTED INTO THE PATIENT'S BODY, THE ECHO SCREEN DISPLAY DISAPPEARED MIDWAY AND IT WAS NOT RECOGNIZED. A NEWLY OPENED CATHETER (LOT #: G947359) WAS ALSO NOT RECOGNIZED. THE TIMING WAS WHILE CONFIRMING THE PERICARDIAL EFFUSION. ADDITIONALLY, THE ISSUE WAS RESOLVED BY REPLACING WITH ANOTHER SOUNDSTAR ECO CATHETER (THE SECOND ONE). CF MONITORING METHODS WERE DASHBOARD, VECTOR, AND VISITAG. VISITAG COLORING SETTINGS WAS TAG INDEX. VISITAG ADDITIONAL FILTERS

  Patient problems: Cardiac Tamponade

  MAUDE report 22392341 ↗
• InjuryJun 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED AFTER PVI/SVCI (PULMONARY VEIN ISOLATION / SUPERIOR VENA CAVA ISOLATION) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DECREASE, PERICARDIAL EFFUSION/CARDIAC TAMPONADE INITIALLY TREATED WITH MEDICATION AND THEN DRAINAGE. AFTER THE CATHETERS WERE REMOVED FROM THE PATIENT¿S CARDIAC CAVITY, IT WAS CONFIRMED THAT THE PATIENT¿S BLOOD PRESSURE DECREASED (ABOUT 60MMHG, 60 BPM). NORADRENALINE WAS ADMINISTERED BUT THE PATIENT¿S CONDITION WAS NOT CHANGED. PERICARDIAL EFFUSION WAS CONFIRMED BY BODY SURFACE ECHOCARDIOGRAPHY. AFTER PERICARDIAL DRAINAGE WAS PERFORMED, THE BLOOD PRESSURE INCREASED, AND THE PATIENT LEFT THE ROOM. WHILE THE BLOOD PRESSURE WAS DECREASING, THE PATIENT WOKE UP FROM SEDATION, INITIATED SPONTANEOUS BREATHING, AND WAS RESPONSIVE. INVESTIGATION IS ONGOING REGARDING THE PROGRESS AND EXTENDED HOSPITALIZATION. SINCE THE EVENT OCCURRED AFTER REMOVAL OF THE CATHETERS, THE USED CATHETERS WERE SMART TOUCH SF CATHETER, OCTARAY, SOUNDSTAR, AND ALL WERE DISCARDED. ALSO, A BEEAT CATHETER WAS USED IN THE CORONARY SINUS (CS). PHYSICIAN ASSESSMENT OF THE HEALTH HAZARD WAS NON-SERIOUS

  Patient problems: Cardiac Tamponade

  MAUDE report 22136178 ↗
• InjuryJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. AFTER THE COMPLETION OF THE PROCEDURE, IT WAS CONFIRMED THAT THE PATIENT¿S BLOOD PRESSURE DECREASED. IT WAS CHECKED WHETHER PERICARDIAL EFFUSION WAS PRESENT WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND THERE WAS A PERICARDIAL EFFUSION/CARDIAC TAMPONADE. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS. A SMALL AMOUNT OF BLOOD WAS COLLECTED. THE PATIENT ORIGINALLY HAD LOW BLOOD PRESSURE AND WAS SLIGHTLY BRADYCARDIC, BUT AFTER PERICARDIOCENTESIS, IT WAS REPORTED THAT BLOOD PRESSURE GRADUALLY SHOWED AN UPWARD TREND. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT IT WAS NOT DUE TO A DEFECT IN THE PRODUCTS, AND ASSESSMENT OF THE HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). NO EXTENDED HOSPITALIZATION WAS INITIALLY REPORTED. CAUSAL RELATIONSHIP WITH PRODUCT WAS UNKNOWN. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. PATIENT MEDICAL HISTORY AND CONCOMITANT DISEASES WERE THE LAST TIME, THE AF CASE WAS TREATED WITH RF. THIS TIME, THE 2ND CASE WAS ALSO PERFORMED

  Patient problems: Arrhythmia; Cardiac Tamponade

  MAUDE report 22122882 ↗
• InjuryMay 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND 6 HOURS AFTER THE CATHETER WAS USED, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION/CARDIAC TAMPONADE TREATED WITH DRAINAGE. PROLONGED HOSPITALIZATION WAS NOTED, AND PATIENT¿S VITAL SIGNS STABILIZED. DURING PVC TREATMENT, IT WAS DISCOVERED THAT THE CARDIAC MOTION WAS SMALL WHILE CONFIRMING FLUOROSCOPY ALMOST 6 HOURS AFTER CATHETER USE, AND THE ACCUMULATION OF PERICARDIAL EFFUSION/CARDIAC TAMPONADE WAS CONFIRMED USING THE SOUND STAR ECO CATHETER. IT WAS DETERMINED THAT THE CAUSE WAS NOT RELATED TO THE PRODUCTS, AND DRAINAGE WAS PERFORMED PROMPTLY. THE VITAL SIGNS STABILIZED. THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH PROBLEM WAS THAT IT WAS NON-SERIOUS (MODERATE/MINOR). THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THERE WAS NO CAUSAL RELATIONSHIP. PROLONGATION OF HOSPITAL STAY WAS NOTED. CONTACT FORCE (CF) VISUALIZATION/MONITORING METHODS INCLUDED REAL TIME GRAPH; DASHBOARD; VECTOR. COLORING SETTING OF VISITAG WAS TAG INDEX. ADDITIONAL FILTER FOR VISITAG WAS FORCE OVER TIME (FOT). NO ABNORMALITIES WERE OBS

  Patient problems: Cardiac Tamponade

  MAUDE report 22064141 ↗
• MalfunctionMay 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF WHICH HAD A FOREIGN MATERIAL IN THE CONNECTOR SECTION WHICH WAS INTRODUCED INTO THE STERILE FIELD. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AT THE TIME OF OPENING THE CATHETER, THERE WAS A FOREIGN OBJECT IN THE CABLE CONNECTION AREA, PREVENTING THE CATHETER FROM BEING CONNECTED TO THE CABLE. THE ISSUE WAS RESOLVED BY REPLACING THE SMART TOUCH SF CATHETER AND THE CABLE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE AS THE DEVICE WAS NOT USED ON THE PATIENT. THE CUSTOMER'S REPORTED FOREIGN MATERIAL IN THE CONNECTION PORT WAS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 24-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS ACTUALLY INTRODUCED INTO THE STERILE FIELD AND WAS CONNECTED TO A CATHETER AT THE FEET SIDE OF THE PATIENT WHO WAS COVERED WITH A DRAPE. BASED ON THIS NEW INFORMATION, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P