THERMOCOOL SMARTTOUCH SF D134702Recalls & reported problems

Summary

The FDA's MAUDE database contains 366 adverse event reports that list this exact device (DI 10846835009781), received between Aug 24, 2017 and Aug 3, 2026 — classified as 19 deaths, 201 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (122 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 366 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Material Twisted/Bent; Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia (VT) with a ThermoCool SmarTouch SF catheter and the patient experienced cardiac tamponade that required pericardiocentesis.First, it was reported that during the procedure, a dysfunction of the 3D representation of the catheter was observed. The movements visualized in space were abnormal and did not correspond to the movements and position observed under fluoroscopy. In order to characterize the malfunction, the catheter was moved into the cavity to determine its location and understand the resulting 3D representation. No errors reported on the system. The green and yellow patches were checked and reported to have good association of cables and magnetic sensors. They restarted Patient Interface Unit (PIU) and software. Following these actions, the doctor indicated a return to normal system behavior. However, a fold at the base of the catheter was then observed (pleating at the base without manipulation with high force), motivating its replacement. The catheter was replaced.The procedure was successfully continued and the patient was discharged from the ward without immediate vital complications. Subseq

  Patient problems: Cardiac Tamponade

  MAUDE report 50115452 ↗
• InjuryMay 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED DRAIN PLACEMENT AND SURGERY. DURING THE ABLATION PROCEDURE, IMMEDIATELY FOLLOWING THE TRANSEPTAL PUNCTURE, THE ABLATION CATHETER APPEARS TO HAVE PERFORATED THE ANTERIOR WALL OF THE LEFT ATRIAL APPENDAGE. THE CATHETER WAS WITHDRAWN AND THE PROCEDURE CONTINUED. THERE WAS THEN NOTICEABLE PERICARDIAL EFFUSION ON THE TOE (TRANSESOPHAGEAL ECHOCARDIOGRAM) AND AS SUCH A PERICARDIAL DRAIN WAS INSERTED TO DRAIN THIS EFFUSION. THE PROCEDURE WAS CONTINUED AND ABLATION COMPLETED. THE CATHETERS WERE REMOVED AND THE PATIENT WAS MONITORED IN THE LAB. HOWEVER, THE EFFUSION CONTINUED TO INCREASE AND BLOOD WAS CONTINUOUSLY DRAINED. SUBSEQUENTLY, THE PATIENT REQUIRED CARDIAC SURGERY IN THE LAB TO CLOSE THE PERFORATION. THE PATIENT REMAINED STABLE THROUGHOUT. IT WAS REPORTED THAT THE PATIENT REQUIRED A 4-DAY STAY FOLLOWING SURGERY. THE OPERATOR BELIEVES THAT DUE TO THE SIZE OF THE LEFT ATRIUM AND THE EASE OF TRANSEPTAL THROUGH THE PFO (PATENT FORAMEN OVALE) CAUSED A MISJUDGMENT OF THE CATHETER LOCATION.

  Patient problems: Cardiac Perforation

  MAUDE report 25311245 ↗
• InjuryMay 21, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED A STROKE. NO ADDITIONAL RELEVANT INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Stroke/CVA

  MAUDE report 25247494 ↗
• DeathMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT WHO UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH SF CATHETER EXPERIENCED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE ABLATION PHASE OF THE PROCEDURE, THE PHYSICIAN CHECKED FOR ANY PERICARDIAL EFFUSION AND WAS ABLE TO CONFIRM ONE USING INTRACARDIAC ECHOCARDIOGRAPHY AND NOTING A DROP IN THE PATIENT'S BLOOD PRESSURE. AS A RESULT, A PERICARDIOCENTESIS WAS PERFORMED. SOMETIME AFTER THE INTERVENTION OCCURRED, THE PATIENT EXPIRED. PER THE PHYSICIAN, THE HARM MAY HAVE OCCURRED LATE IN THE PROCEDURE WHILE ABLATING THE CAVOTRICUSPID ISTHMUS LINE WITH THE SMART TOUCH CATHETER. NO STEAM POPS WERE NOTED DURING THE CASE.

  Patient problems: Cardiac Tamponade

  MAUDE report 25234609 ↗
• MalfunctionApr 3, 2026Image Orientation Incorrect; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. A THERMOCOOL SMARTTOUCH SF CATHETER WAS INSERTED INTO THE LEFT ATRIUM FOR A REDO ATRIAL FIBRILLATION PROCEDURE. THE CATHETER WAS ZEROED AND NO ERRORS WERE SEEN ON THE CARTO. THE FIRST ABLATION BEGAN AND THE FORCE READING JUMPED FROM 15G TO OVER 50G AND THE VECTOR APPEARED TO POINT BACK INTO THE CATHETER. ABLATION WAS TERMINATED IMMEDIATELY. THE CATHETER WAS RE-ZEROED AND MOVED INTO A NEW POSITION, BUT THE SAME RESPONSE OCCURRED WHEN ABLATION BEGAN. THE CABLE WAS CHANGED BUT THE PROBLEM PERSISTED. WHEN THE CATHETER WAS REMOVED FROM THE BODY, THERE WAS BLOOD NOTED IN THE CHAMBER WITH THE SPRING. THE CATHETER WAS REPLACED AND THE CASE PROCEEDED UNINTERRUPTED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE BOSTON SCIENTIFIC, SUREFLEX STEERABLE GUIDING SHEATH, 8.5F WAS USED. NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. THE CATHETER PEBAX DID NOT APPEAR CRACKED NOR BROKEN. THE BIOSENSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779078 ↗
• InjuryMar 5, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION WITH THE THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED DROPPED IN BLOOD PRESSURE, DISCOMFORT AND PERFORATION TREATED WITH PERICARDIOCENTESIS. THE PATIENT REQUIRED MEDICAL TREATMENT FOR THE LOW BLOOD PRESSURE AND WAS REQUIRED 2 DAYS OF PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING THE CARDIAC ABLATION PROCEDURE, PERFORATION WITH THE THERMOCOOL SMARTTOUCH SF UNID CATHETER WAS SUSPECTED. THE PATIENT HAD A PERICARDIAL EFFUSION. THEY NOTICED A DROP IN BLOOD PRESSURE, AND THE PATIENT REPORTED DISCOMFORT. THEY CONFIRMED THE EFFUSION ON TRANSTHORACIC ECHO. PERICARDIOCENTESIS WAS PERFORMED AND THEY ARE NOT SURE HOW MUCH FLUID WAS DRAINED. THERE WAS MEDICAL INTERVENTION PROVIDED TO THE PATIENT FOR THE BLOOD PRESSURE, BUT THEY WERE NOT SURE EXACTLY WHAT. THE PATIENT IS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PERFORATION CROSSING THE AORTIC VALVE. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF 2 OVERNIGHT STAY

  Patient problems: Cardiac Perforation

  MAUDE report 24527542 ↗
• InjuryMar 5, 2026Electrical Shorting; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED SURGERY. A CARDIAC TAMPONADE WAS NOTICED DURING THE PROCEDURE. THE FELLOW HAD THEIR HAND ON THE ABLATION CATHETER AND WAS HAVING DIFFICULTY GETTING THE RIGHT SPOT. WHEN THE ATTENDING PUT HIS HANDS BACK ON THE ABLATION CATHETER, IT WAS NOTICED THAT THE ABLATION CATHETER DISPLAYED ON THE CARTO 3 SYSTEM APPEARED TO BE OUTSIDE OF THE GEOMETRY AND APPEARED TO BE OUTSIDE OF THE CARDIAC SILHOUETTE ON FLUOROSCOPY. THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT REQUIRED A PERICARDIOCENTESIS. ONCE BLOOD STARTED BEING PULLED BACK, THE CARDIAC TAMPONADE WAS CONFIRMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT WAS TRANSFERRED TO OPERATING ROOM (OR) FOR SURGERY FOR REPAIR. ONE RADIO FREQUENCY (RF) LESION WAS DISPLAYED AS OUTSIDE OF THE GEOMETRY. THE PATIENT¿S STATUS WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED. THERE WERE TWO TRANSSEPTAL PUNCTURE SITES PERFORMED DURING THE PROCEDURE WITH A BAYLISS NRG C1 NEEDLE. TYPICAL SETTINGS FOR SF CATHETER WERE USED WITH DIFFERENT POWERS. THE PHYSICIAN'S OPINION O

  Patient problems: Cardiac Perforation

  MAUDE report 24520085 ↗
• MalfunctionMar 4, 2026Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING RADIO FREQUENCY (RF) ABLATION, WHEN THE CABLE WAS CONNECTED TO THERMOCOOL SMARTTOUCH SF CATHETER, ERROR CODE 105 ¿MAP: CATHETER SENSOR ERROR¿ AND ERROR CODE 106 ¿FORCE CATHETER SENSOR ERROR¿ OCCURRED. REPLACING THE CABLE AT THE TIME, DID NOT RESOLVE THE ISSUE. REPLACED THE CATHETER. THE ISSUE WAS RESOLVED AFTER REPLACING THE CATHETER. NO PATIENT CONSEQUENCE REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 09-FEB-2026, OBSERVED A HOLE IN THE SURFACE OF THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE SURFACE OF THE PEBAX ON 09-FEB-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510145 ↗
• MalfunctionFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ¿ PERSISTENT ABLATION PROCEDURE WITH AN THERMOCOOL SMARTTOUCH SF (STSF) CATHETER AND THE FORCE READING WAS HIGH. IN THE LEFT ATRIUM, THE ¿ZERO FORCE STSF CATHETER WAS FALSE¿ WHEN IT WAS IN THE LEFT ATRIUM. THERE WERE NO ERRORS DISPLAYED. THEY CHANGED THE CABLE. THEY DID ZERO FORCE OUTSIDE THE PATIENT, AND THEY SAW BLOOD ON THE TIP OF THE CATHETER. AFTER CHANGING THE CATHETER, THE ISSUE WAS RESOLVED. THE SURGERY WAS DELAYED BY TEN MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND SCREENING TEST WERE PERFORMED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED PEBAX SLIPPED WITH INTERNAL PARTS EXPOSED AND REDDISH-BROWN MATERIAL ON THE PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280657 ↗
• MalfunctionFeb 3, 2026Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT DURING AN ATYPICAL FLUTTER PROCEDURE, AFTER STARTING ABLATION WITH THE CATHETER THE MEDICAL TEAM GOT THE BUBBLE ALARM FROM THE SMARTABLATE GENERATOR. WHEN FLUSHING, THE TEAM NOTICED THAT THERE WAS BLOOD FLOWING BACK INTO THE TUBING UP UNTIL THE PUMP SENSOR. THE TUBING WAS CHECKED AND CONFIRMED TO BE POSITIONED CORRECTLY. FLUSHING WAS ATTEMPTED BY OPENING THE 3-WAY TAB TO AIR, AND AFTER RECONNECTION THE CATHETER WAS FLUSHED BUT NO FLOW WAS SEEN. THE TUBING WAS THEN DISCONNECTED FROM THE CATHETER, AND A SYRINGE FLUSH WAS ATTEMPTED INSTEAD BUT THERE WAS EXTREME RESISTANCE. THE DEVICE HAD ALREADY BEEN USED INSIDE OF THE PATIENT PRIOR TO NOTING THE IRRIGATION ISSUE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO FLOW RATE CHANGE ISSUES AT THE START OF ABLATION. THE CATHETER WAS REPLACED (AND THE SAME TUBING WAS USED) AND THE ISSUE RESOLVED. AFTER AN APPROXIMATELY TROUBLESHOOTING PERIOD OF 5 MINUTES, THE PROCEDURE CONTINUED. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248676 ↗
• MalfunctionJan 28, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NON-ISCHEMIC VENTRICULAR TACHYCARDIA (NON-ISVT) ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND IRRIGATION DID NOT WORK AS USUAL. AFTER MAPPING IN THE RIGHT VENTRICLE, IT WAS DECIDED TO MAP IN THE LEFT, BUT WHEN THE CATHETER WAS PULLED OUT, IT WAS NOTICED THAT IRRIGATION DID NOT WORK AS USUAL; NOT ALL HOLES IRRIGATION OCCURRED. ACTIVATED CLOTTING TIME (ACT) KEPT ABOVE 300 DURING ALL THE PROCEDURE. THERE WERE NO PROBLEMS IN THE COURSE OF MAPPING, THERE WAS NO ABLATION. THE IRRIGATION LINE RE-CHECKED AND EVERYTHING WAS FINE. IT WAS DECIDED TO REPLACE THE CATHETER TO AVOID POSSIBLE COMPLICATIONS, THE MORE MAPPING CONTINUED IN THE AORTA. AFTER THE CHANGE OF THE CATHETER, THE OPERATION WAS CONTINUED AND ENDED WITHOUT COMPLICATIONS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200489 ↗
• MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND AN ISSUE WITH WRONG FORCE ON CATHETER, NOT ABLE TO ZERO PROPERLY WAS OBSERVED. IT SHOWED "HIGH FORCE" WHEN NOT IN CONTACT WITH TISSUE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED THAT THE PEBAX WAS BROKEN. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090692 ↗
• MalfunctionDec 30, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV NODE ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER. THE THERMOCOOL SMARTTOUCH SF CATHETER WAS IN THE BODY WHEN THEY NOTICED IT WOULD NOT IRRIGATE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. IT WAS A BRAND NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930694 ↗
• InjuryDec 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE, TACHYCARDIA AND A SMALL PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED AND WENT HOME 2 DAYS LATER, POSSIBLY 3. THE REPORT INDICATED THAT A PERICARDIAL EFFUSION WAS NOTICED MID-PROCEDURE. THE PATIENT WAS NOTICED TO HAVE HIGH BLOOD PRESSURE AND TACHYCARDIA MID-CASE. A SMALL PERICARDIAL EFFUSION WAS RECOGNIZED AND CONFIRMED ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY. 500ML OF BLOOD WAS DRAINED. THE PROCEDURE CONTINUED AND WAS COMPLETED. THE PATIENT RETURNED TO THE ROOM, BUT THE STAFF WAS BRINGING THE PATIENT DOWN FOR PERICARDIOCENTESIS. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE DEVICES USED DURING THE CASE WERE OCTARAY CATHETER, SOUNDSTAR CATHETER, AND STSF CATHETER (NAV). THE BWI CATHETERS WERE DISCARDED, AND UNABLE TO PROVIDE THE DETAILS FOR THE BWI CATHETERS. THE BWI CATHETERS WERE BRAND NEW. THE PERICARDIAL EFFUSION WAS FOUND, THE FARAPULSE SYSTEM HAD BEEN USED FOR ABLATION. THE SMARTABLATE GENERATOR WAS UTILIZED NEAR THE END OF THE CASE FOR AN ATRIAL FLUTTER. THE CARTO 3 SYSTEM WAS USED FOR THE P

  Patient problems: Cardiac Tamponade

  MAUDE report 23911649 ↗
• InjuryDec 19, 2025High Readings; Patient Device Interaction Problem; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TYPICAL FLUTTER ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH SF (STSF) CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH PERICARDIOCENTESIS. TYPICAL FLUTTER ABLATION WAS COMPLETED USING A CARTO V8 MAPPING SYSTEM, STSF-F CURVE ABLATOR, AND AN ABBOTT INQUIRY DECA CATHETER. A SR0 SHEATH WAS ADDED FOR BETTER CONTACT. ON THE 9TH ABLATION, THERE WAS AN IMPEDANCE RISE AFTER 24S OF RADIOFREQUENCY (RF), FOLLOWED BY A STEAM POP. SHORTLY AFTER THE PRESSURE DROPPED, THE CARDIAC ¿SILHOUETTE WAS NO LONGER MOVING ON XRAY¿. ULTRASOUND WAS DONE CONFIRMING A TAMPONADE, TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS THEN ALSO DONE TO MONITOR THE PERICARDIOCENTESIS, AND 400CC OF BLOOD WAS REMOVED. THE PATIENT WAS STABILIZED AND WAS EVENTUALLY TRANSFERRED TO CRITICAL CARE UNIT (CCU) FOR RECOVERY/MONITORING. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE EVENT, INSTEAD OF SAME DAY DISCHARGE PROCEDURE, AS IS USUALLY DONE. THE PATIENT STATUS/OUTCOME FOLLOWING THE EVENT WAS STABLE UPON TRANSFER TO CCU, AND UNKNOWN AFTER THAT. A SIGNIFICANT DELAY WAS NOTED LASTING 75 MINUTES. ADDITIONAL CLARIFYING INFORMATION WAS RECEIVED REGARDING PREVIOUS

  Patient problems: Cardiac Tamponade

  MAUDE report 23857964 ↗
• MalfunctionDec 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, AFTER THE MAP WAS MADE WITH THE OCTARAY IN THE LEFT ATRIUM, ABLATION WAS STARTED. HOWEVER, THE VISUALIZATION OF ABLATION CATHETER JUMPED ON CARTO. NO ACTUAL MOVEMENT OF CATHETER IN THE LEFT ATRIUM WAS SEEN ON FLUOROSCOPY. THE ABLATION CATHETER CABLE BUT THE ISSUE PERSISTED. THE CATHETER WAS EXCHANGED AND THAT RESOLVED THE ISSUE. THE CASE CONTINUED AND WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707856 ↗
• MalfunctionNov 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THERE WAS BLOOD IN THE FORCE SENSOR DESPITE SEVERAL ATTEMPTS TO REMOVE IT. ACCORDING TO THE DOCTOR, THE PLASTIC AROUND THE FORCE SENSOR SEEMED MORE ELASTIC THAN USUAL AND DIDN'T APPEAR TO BE SEALED AGAINST THE REST OF THE UNIT AND BLOOD COULD EASILY GET TRAPPED INSIDE. THERE WAS NO DIFFICULTY IN REMOVING OR MANEUVERING THE CATHETER. THERE WAS A 2-MINUTE SURGICAL DELAY FROM TROUBLESHOOTING. NO FURTHER DETAILS WERE PROVIDED REGARDING THE TROUBLESHOOTING OF THE ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648123 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING NON-ISCHEMIC VENTRICULAR TACHYCARDIA (NON-ISVT)-RIGHT/PVC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIAL PUNCTURE. IT WAS REPORTED THAT DURING A PVC/NON-ISVT (RIGHT) CASE, AND AFTER ABLATION WITH A STSF CATHETER IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), A PERICARDIAL EFFUSION WAS IDENTIFIED. THE PATIENT WAS STABLE AFTER THE PERICARDIAL PUNCTURE. THE MAXIMUM FORCE VALUE 48G. THE CASE WAS COMPLICATED BECAUSE THE PERICARDIAL EFFUSION WAS IDENTIFIED AFTER ABLATION AND DURING VERIFICATION TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT ¿SOMETIMES IT HAPPENS¿. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE ENERGY SOURCE USED WHEN THE ADVERSE EVENT OCCURRED WAS RADIOFREQUENCY (RF). NO GENERATOR/PUMP MALFUNCTION WAS REPORTED. NO ABLATIONS WERE PERFORMED WITHIN NOR OUTSIDE THE PULMONARY VEINS.

  Patient problems: Cardiac Tamponade

  MAUDE report 23646876 ↗
• InjuryNov 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT AFTER THE SUCCESSFUL RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE, WHILE THE PATIENT WAS IN THE RECOVERY AREA, BLOOD PRESSURE STARTED TO DROP. A TRANSTHORACIC ECHO REVEALED A TRACE OF PERICARDIAL EFFUSION. THE PATIENT STATUS CONTINUED TO DECLINE, SO THE PATIENT WAS BROUGHT BACK TO THE ELECTROPHYSIOLOGY (EP) LAB WHERE THEY RECEIVED PERICARDIOCENTESIS. INTERVENTION WAS ONGOING AT THE TIME OF THE CALL. PATIENT STATUS WAS UNKNOWN. THERE WAS NOTHING ABNORMAL THAT OCCURRED DURING THE ABLATION PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 23640760 ↗
• MalfunctionOct 30, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF WHICH WOULD NOT "HIGH" FLUSH FROM THE PUMP. IT WAS ALSO REPORTED THAT THE THERMOCOOL SMARTTOUCH SF DISPLAYED A "HI TEMP WARNING." THE CALLER STATED THAT THE CATHETER WAS REMOVED FROM THE BODY, AND NO CHAR WAS NOTICED ON THE CATHETER TIP. THE CALLER NOTED THAT THE CATHETER WAS FLUSHED BUT WOULD NOT "HIGH" FLUSH FROM THE PUMP. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THE CALLER NOTED THE CATHETER WAS BRAND NEW. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430844 ↗
• MalfunctionOct 30, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX SURFACE. INITIALLY IT WAS REPORTED THAT WHEN CONNECTING THE CATHETER, THERE WAS A CATHETER SENSOR ERROR MESSAGE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. UNSURE WHICH SENSOR FAILED (MAGNETIC, FORCE, TEMPERATURE); HOWEVER, IT SHOULD BE THE ERROR 106 - FORCE SENSOR ERROR. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 07-OCT-2025, OBSERVED REDDISH MATERIAL INSIDE THE PEBAX SLEEVE. DUE TO THIS CONDITION, THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND A HOLE ON THE PEBAX SURFACE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE PEBAX SURFACE ON 07-OCT-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425436 ↗
• MalfunctionOct 27, 2025Signal Artifact/Noise; Contamination /Decontamination Problem; Signal Artifact/Noise; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) CATHETER AND AS THEY WERE IN THE MIDDLE OF A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION, AT SOME POINT, THEY WERE GETTING HEAVY ARTIFACTS ON THE STSF 1-2 SIGNALS DURING ABLATION. THEY PULLED OUT THE CATHETER AND COULD OBSERVE BLOOD INSIDE OF THE TRANSPARENT PART OF THE CATHETER TIP. THEY IMMEDIATELY REPLACED THE CATHETER AND FINISHED THE PROCEDURE WITHOUT ANY FURTHER ISSUES. THE PHYSICIAN DID NOT REPORT ANY DIFFICULTIES MANEUVERING. THEY COULD NOT IDENTIFY ANY VISIBLE CRACKS THAT CAN BE SEEN WITH THE NAKED EYE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, MICROSCOPY AND ELECTRICAL EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394264 ↗
• InjuryOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN AFIB ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT EXPERIENCED STROKE. THE PATIENT WAS TRANSFERRED TO ICU, AND THE FOLLOWING DAY, THE PATIENT HAD A SECOND STROKE. ADDITIONALLY, 3 OF THE 4 THERMOCOOL SMARTTOUCH SF CATHETERS HAD FORCE ERROR CODES THAT WAS RESOLVED WITH RESETTING THE CARTO 3 SYSTEM PIU (PATIENT INTERFACE UNIT). THE INFORMATION RECEIVED INDICATED THAT DURING ABLATION PROCEDURE WITH A STSF AND PENTARAY CATHETER USED IN THE LEFT ATRIUM VIA AN AGILIS STEERABLE SHEATH FROM ABBOTT. DURING THE CASE (WITHOUT BIOSENSE SUPPORT) THE MEDICAL TEAM INDICATED THAT THEY HAD ISSUES WITH THE STSF CATHETER, AND THEY COULDN´T ZERO THE CATHETER FORCE AND A FORCE SENSOR ERROR OCCURRED ON THE CARTO SYSTEM. USING NORMAL TROUBLESHOOTING ROUTINE, THEY CHANGED THE CONNECTION CABLE TO A NEW ONE, BUT ERROR REMAINED. A NEW CATHETER WAS THEN TRIED SUCCESSFULLY WITH A FUNCTIONING FORCE SENSOR. THE SECOND STSF CATHETER THEN HAD MAGNETIC SENSOR WARNINGS IN CARTO, AND IT APPEARED IN CARTO SCREEN ON NORMAL DESIRED POSITION BUT ROTATED AROUND ITS TIP CONSTANTLY. THEY AGAIN RECONNECTED EVERYTHING AND MADE SURE ALL CONNECTIONS WERE FINE, BU

  Patient problems: Stroke/CVA

  MAUDE report 23341214 ↗
• MalfunctionSep 18, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED. THEY GOT A MAGNETIC SENSOR ERROR # 105 WHEN THE THERMOCOOL SMARTTOUCH SF CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU) ON THE CARTO 3 SYSTEM. CHANGING OUT THE CATHETER CABLE DID NOT RESOLVE THE ERROR. CHANGING OUT THE CATHETER RESOLVED THE ERROR AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2025, OBSERVED REDDISH BROWN MATERIAL INSIDE AND A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED ON (B)(6) 2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088842 ↗
• InjurySep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND CARDIAC SURGERY. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE CATHETER INTO THE CORONARY SINUS, AND THERE WAS A DROP IN IMPENDENCE. THE DOCTOR PROCEEDED TO ABLATE INSIDE THE CORONARY SINUS, AND THE PRESSURE AND ULTRASOUND WAS "FINE." FIVE MINUTES LATER THEY PULLED BACK AND WENT TO THE LEFT SIDE OF THE HEART, AND INTO THE "LVOT" (LEFT VENTRICULAR OUTFLOW TRACT). THEY WERE ABLATING WHEN SOMEONE NOTICED A DROP IN PRESSURE. THE ULTRASOUND WAS CHECKED, AND THEY NOTICED AN EFFUSION. THEY PROCEEDED TO DO A "TAP." PERICARDIOCENTESIS WAS PERFORMED, AND 600 MIL WAS REMOVED. THE PATIENT WAS TRANSPORTED FOR CARDIOTHORACIC SURGERY. THE INJURY WAS LISTED AS A CARDIAC PERFORATION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THEY FELT THE CATHETER PERFORATED THE CS (CORONARY SINUS) WITH THE ADDITIONAL SUPPORT PROVIDED WHEN ADVANCING THE AGILIS SHEATH. THE INTERVENTION PROVIDED WAS SURGERY, AND DURING SURGERY IT WAS NOTED THAT THE BLEEDING HAD STOPPED, AND THEY

  Patient problems: Cardiac Perforation

  MAUDE report 23053779 ↗

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-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-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-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-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-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-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