THERMOCOOL SMARTTOUCH SF D134804Recalls & reported problems

Summary

The FDA's MAUDE database contains 784 adverse event reports that list this exact device (DI 10846835010176), received between Nov 7, 2016 and Sep 28, 2026 — classified as 44 deaths, 500 injuries, 240 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (288 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 784 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923149 ↗
• InjuryAug 27, 2026Patient Device Interaction Problem

  Patient received a repeat cardiac ablation procedure with a THERMOCOOL SMARTTOUCH SF on (b)(6)2026 and suffered experienced cardiogenic shock. The cardiogenic shock (Adverse Event #2) was categorized as mild and serious defined by hospitalization with an admission date of (b)(6)2026 and an end date of (b)(6)2026. Relationship to study device is not related and the relationship to the repeat study procedure is probable. The adverse event was reported as anticipated. The outcome is resolved with an end date of (b)(6)2026. Intervention was medication (Dobutamine).

  Patient problems: Cardiogenic Shock

  MAUDE report 50466019 ↗
• MalfunctionMay 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THEY HAD HIGH FORCE READINGS ON THE CARTO 3 SYSTEM. CALLER TRIED REZEROING SEVERAL TIMES WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED FORCE ISSUE IS 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 (B)(6) 2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306129 ↗
• MalfunctionMay 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) AND IN THE MIDDLE OF THE PROCEDURE, THE PHYSICIAN FELT WHAT SEEMED LIKE A STEAM POP DURING A CAVOTRICUSPID ISTHMUS (CTI) PROCEDURE. THE ABLATION TAG WHERE HE FELT THE STEAM POP HAD AN AVERAGE CONTACT FORCE OF 11G (5-18G) AND AN ABLATION INDEX OF 555. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PERICARDIAL EFFUSION WAS FOUND BY THE PHYSICIAN USING ECHOCARDIOGRAPHY AFTER THE PROCEDURE. ABLATION MODE WAS POWER-CONTROLLED. TEMPERATURE WAS 26° (IRRIGATED CATHETER), IMPEDANCE WAS 118-111, FORCE WAS 5-18G (11G ON AVERAGE). THE LENGTH OF THE ABLATION CYCLE WHEN THE POP WAS OBSERVED AT THE SAME TIP POSITION WAS 24 SECONDS. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167185 ↗
• MalfunctionApr 28, 2026Insufficient Cooling; Device Contamination with Body Fluid; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND AN IRRIGATION ISSUE OCCURRED DURING USE IN THE PATIENT. IT WAS REPORTED THAT AFTER ADVANCING THE THERMOCOOL SMARTTOUCH SF CATHETER INTO THE BODY AND THEY STARTED ABLATION, IT WAS NOTICED THAT THE IRRIGATION FLOW RATE FOR THE THERMOCOOL SMARTTOUCH SF CATHETER WAS FLOWING AT 2ML/MIN, COMPARED TO THE NORMAL 8-15ML/MIN FLOW RATE. THE CALLER ADVISED THAT THEY WERE NOT INSIDE THE ROOM AT THE TIME, AND THEY WERE NOT ABLE TO CONFIRM IF THE CATHETER SETTING FOR THE THERMOCOOL SMARTTOUCH SF CATHETER HAD BEEN CHANGED OR ADJUSTED ON THE SMARTABLATE® PUMP. THE CALLER THEN REPORTED THAT THE TEMPERATURE READING ON THE TIP OF THE THERMOCOOL SMARTTOUCH SF CATHETER HAD INCREASED, UNTIL IT WAS ABOVE 45 DEGREES. UPON REMOVING THE THERMOCOOL SMARTTOUCH SF CATHETER FROM THE BODY, IT WAS NOTICED THAT THERE WAS CHAR RESIDUE ON THE TIP OF THE THERMOCOOL SMARTTOUCH SF CATHETER. THERE WAS NO CONSEQUENCE OR INJURY TO THE PATIENT. THE THERMOCOOL SMARTTOUCH SF CATHETER WAS REPLACED, THE CALLER CONFIRMED THAT THE THERMOCOOL SMARTTOUCH SF CATHETER FLOW SETTING WAS CORRECT ON THE SMARTABLATE PUMP, AND THE ISSU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016134 ↗
• MalfunctionMar 19, 2026Failure to Sense; Obstruction of Flow; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. IT WAS ALSO REPORTED THAT THE THERMOCOOL SMARTTOUCH® SF CATHETER WAS ADVANCED INTO THE BODY AND WHEN THEY ATTEMPTED TO COME ON ABLATION, THE NGEN¿ MONITOR DISPLAYED AN ERROR, "CATHETER TIP TEMPERATURE." THE CALLER COULD NOT CONFIRM THE ERROR CODE. THE IRRIGATION WAS CHECKED AND THEY NOTICED THE TUBING WAS COILED. THE CALLER STATED THE TUBING WAS UNCOILED, FLUSHED AND THEY NOTICED THE IRRIGATION WAS NOT EXITING THE CATHETER TIP. THE CATHETER WAS DISCONNECTED, THE TUBING WAS FLUSHED AND CONFIRMED IT WAS FINE. THE CALLER STATED THEY RECONNECTED THE TUBING TO THE CATHETER AND THE IRRIGATION DID NOT FUNCTION WITH THE CATHETER. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646322 ↗
• MalfunctionMar 18, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Sense; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR (AV) NODE ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF, AND WHEN COMING ON ABLATION, THERE WERE HIGH FORCE READINGS, AND INTERMITTENT HIGH MAGNETIC FIELD ISSUES. THERE WERE NO ERRORS DISPLAYED. THE CATHETER AND CABLE WERE RESEATED WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CATHETER TIP WAS WIPED AND THERE WAS BLOOD INSIDE THE SENSOR COIL TUBING. THE REPORTER NOTED THAT IT WAS A BRAND-NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. 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, MAGNETIC AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627746 ↗
• InjuryMar 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIDED IDIOPATHIC PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE THAT REQUIRED A PERICARDIOCENTESIS AND DRAIN PLACEMENT. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH WAS OBSERVED BY A PRESSURE DROP AND CONFIRMED BY TRANS THORACIC ECHO. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 500 CC'S WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE STABLE AND WAS TRANSFERRED TO THE CARDIAC CARE UNIT (CCU) FOR OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED. PATIENT STAYED OVERNIGHT IN THE INTENSIVE CARE UNIT (ICU) FOR DRAIN MANAGEMENT. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PERFORATION. THE EVENT OCCURRED DURING MAPPING OR ABLATION, ABLATION WAS PERFORMED PRIOR TO NOTING THE ADVERSE EVENT. NO TRANSSEPTAL PUNCTURE PERFORMED. NO EVIDENCE OF A STEAM POP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. OTHER RELEVANT PATIENT HISTORY INCLUDES LOW EF (EJECTION FRACTION).

  Patient problems: Cardiac Tamponade

  MAUDE report 24558936 ↗
• InjuryFeb 24, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A PERFORATION OF THE CORONARY SINUS WHICH REQUIRED A PERICARDIOCENTESIS AND CHEST TUBE PLACEMENT. THE PATIENT WAS TRANSFERRED TO CICU. THE REPORT INDICATED THAT AFTER PLACING MULTIPLE PACEMAKER DEVICE LEADS, THE PHYSICIAN INSERTED THE THERMOCOOL SMARTTOUCH SF CATHETER TO PERFORM AN AV NODE ABLATION PROCEDURE. AT THIS POINT, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND NOTED THE PERFORATION OF THE CORONARY SINUS, AND CONTRAST WAS SEEN ENTERING THE PERICARDIAL SPACE. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 250CC'S OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT IS STABLE AND TRANSPORTED TO THE UNIT FOR OBSERVATION AND POSSIBLE FURTHER MEDICAL INTERVENTION. NO ABLATIONS WERE PERFORMED DURING THIS PROCEDURE. NGEN SYSTEM WAS PRESENT BUT NOT USED. CARTO 3 SYSTEM WAS USED FOR THE PROCEDURE. THE ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INTERVENTION PROVIDED WAS PERICARDIAL DRAIN AND CHEST TUBE. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE OUTCOME OF THE ADVERSE EVENT WAS ON GOING AND STILL ADMITTE

  Patient problems: Cardiac Perforation

  MAUDE report 24436309 ↗
• InjuryFeb 23, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND EXPERIENCED THAT THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE PATIENT HAD NO HEART RHYTHM AND CONFIRMED THIS ON EKG. THE PATIENT CAME OUT OF HEART BLOCK WHILE STABLE AND UNDER OBSERVATION AND ARE TWO TO ONE. THE PHYSICIAN IS PUTTING A PACEMAKER IN THE PATIENT, BUT THE PATIENT IS CONDUCTING ON THEIR OWN. WHILE ABLATING WITH THE THERMOCOOL SMARTTOUCH SF CATHETER, IT WAS NOTICED THAT THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE PATIENT HAD NO HEART RHYTHM AND CONFIRMED THIS ON EKG. THE PATIENT CAME OUT OF HEART BLOCK WHILE STABLE AND UNDER OBSERVATION AND ARE TWO TO ONE. THE PHYSICIAN IS PUTTING A PACEMAKER IN THE PATIENT, BUT THE PATIENT IS CONDUCTING ON THEIR OWN. THE BIOSENSE WEBSTER, INC. PRODUCTS IN THE BODY DURING THE CASE WERE A WEBSTER CORONARY SINUS CATHETER, THERMOCOOL SMARTTOUCH SF CATHETER, PREFACE SHEATH, AND TWO QUAD CATHETERS (STRYKER REPROCESSED). THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT AV NODE WAS BURNED. THE INTERVENTION PROVI

  Patient problems: Heart Block

  MAUDE report 24421128 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ¿PATHWAY¿ ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED A CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERICARDIAL EFFUSION CARDIAC PERFORATION AND A WERE NOTICED IN THE PATIENT. THE CALLER REPORTED THAT AFTER MAPPING WITH THE THERMOCOOL SMARTTOUCH SF CATHETER, AND WHEN ABLATING ON THE LEFT SIDE, IT WAS NOTICED THAT THE PATIENT WAS VERY "UNCOMFORTABLE." THE PATIENT WAS "SHIFTING, MOANING AND TENSING." AFTER THE PHYSICIAN HAD STOPPED ABLATION, A CARDIAC PERFORATION WAS DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) VIA THE SOUNDSTAR CATHETER. THEN THE CARDIAC PERFORATION AND THE PERICARDIAL EFFUSION WERE CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS, AND ABOUT 200CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. 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: Cardiac Perforation

  MAUDE report 24405941 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED A STEAM POP, HYPOTENSION AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS AND THE PATIENT WENT TO THE OPERATING ROOM (OR) FOR OPEN HEART SURGERY. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION DUE TO OPEN HEART SURGERY TO CLOSE THE HOLE IN THE LEFT VENTRICLE. THE REPORT INDICATED THAT DURING ABLATION WITH A THERMOCOOL SMARTTOUCH SF CATHETER, A STEAM POP WAS HEARD. THE PATIENT BECAME HYPOTENSIVE AND USING A CARTO SOUND CATHETER A PERICARDIAL EFFUSION WAS NOTED. BEFORE THE CASE STARTED THE PATIENT HAD A SMALL PERICARDIAL EFFUSION BUT AFTER THE STEAM POP IT WAS LARGER. THE CATHETER WAS IN THE LEFT VENTRICLE AT THE TIME OF THE STEAM POP. PERICARDIOCENTESIS WAS PERFORMED AND FLUID IS STILL BEING WITHDRAWN. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE STEAM-POP. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS WORSENED. THE EFFUSION REQUIRED REMOVAL OF 2200CC¿S, AND THE PATIENT WENT TO THE OPERATING ROOM (OR) FOR OPEN HEART SURGERY TO CLOSE THE HO

  Patient problems: Cardiac Perforation

  MAUDE report 24158253 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. WHILE ABLATING THE CTI LINE IN THE RIGHT ISTHMUS, TWO STEAM POPS WERE HEARD. THE PATIENT BECAME HYPOTENSIVE. CARTO SOUND WAS USED AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 425CC OF FLUID WAS EXTRACTED. FURTHER INTERVENTION IS UNKNOWN AT THIS TIME. HARDWARE WORKED WITHIN SPECIFICATIONS. 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 24157490 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED DROP IN BLOOD PRESSURE AND PERICARDIAL EFFUSION THAT WAS ATTEMPTED TO BE TREATED WITH PERICARDIOCENTESIS, BUT THE PHYSICIAN HAD ISSUES OR DIFFICULTY PLACING THE WIRE "TO GET THE DRAIN GOING". THE PATIENT WAS THEN ADMITTED TO THE OPERATING ROOM (OR). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND DISCHARGED FROM THE HOSPITAL A FEW DAYS LATER. THE REPORT INDICATED THAT DURING THE CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. AFTER THEY HAD COMPLETED ABLATION ON THE ANTERIOR MITRAL LINE, WITH THE THERMOCOOL SMARTTOUCH SF CATHETER, THE ANESTHESIOLOGIST NOTICED A DROP IN BLOOD PRESSURE ON THE PATIENT ABOUT 10 MINUTES LATER. THE SOUNDSTAR CATHETER WAS RE-INSERTED BACK INTO THE BODY, AND A PERICARDIAL EFFUSION WAS THEN DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THEY CALLED IN A "STAT" ECHO. THE PHYSICIAN HAD ISSUES OR DIFFICULTY PLACING THE WIRE "TO GET THE DRAIN GOING" FOR A PERICARDIOCENTESIS. THE PATIENT WAS THEN ADMITTED TO THE OR. THE LAST PATIENT¿S STATUS WAS THAT THEY WERE IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24147979 ↗
• DeathJan 20, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE CATHETER WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED A LEFT VENTRICULAR PERFORATION, PERICARDIAL EFFUSION AND THE PATIENT EXPIRED. THE REPORT INDICATED THAT DURING THE PROCEDURE THERE WAS A LEFT VENTRICULAR (LV) PERFORATION. THE PATIENT HAD A SEVERE ISCHEMIC LARGE LV SCAR, AND MYOCARDIAL THINNING OF THE LV. THEY MAPPED FOR 15 MINUTES WITH THE OPTRELL CATHETER. THEY WERE AN HOUR INTO THE PROCEDURE, ABLATING AND MAPPING WITH THE THERMOCOOL SMARTTOUCH SF ON THE LATERAL WALL OF THE LV AND NOTICED A SUDDEN DROP IN BLOOD PRESSURE. THE ULTRASOUND (ICE) IMAGING DISPLAYED A LARGE PERICARDIAL EFFUSION. THE ELECTROPHYSIOLOGY (EP) PHYSICIAN PERFORMED PERICARDIOCENTESIS AND REMOVED 500CC OF BLOOD FROM THE UPPER CARDIAC SPACE. THE BLEEDING WAS NOT CONTROLLED, THE CARDIAC SURGEONS WERE CALLED, AND THEY PERFORMED A STERNOTOMY. THEY PATCHED THE HOLE/PERFORATION FOUND ON THE LATERAL WALL OF THE LV. FOUR HOURS AFTER THE PATCH WAS PLACED, DUE TO THINNESS OF THE MYOCARDIAL WALL, THE PATIENT STILL EXPERIENCED BLEEDING AROUND THE PATCH. THE PATIENT STATUS WAS UNSTABLE AND WAS TRANSPORTED TO THE INTENSIVE CAR

  Patient problems: Cardiac Perforation

  MAUDE report 24123443 ↗
• InjuryJan 15, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, AND THE PATIENT EXPERIENCED DROP IN BLOOD PRESSURE AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS WHICH REQUIRED SURGICAL INTERVENTION. THE REPORT INDICATED THAT DURING AN ATRIAL FLUTTER CASE, A PERICARDIAL EFFUSION WAS NOTICED. THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT WHEN THEY WERE SWITCHING TO A VIZIGO SHEATH. THEY HAD COMPLETED ABLATION ON THE CAVOTRICUSPID ISTHMUS (CTI) LINE WITH A THERMOCOOL SMARTTOUCH SF CATHETER WHEN THE PERICARDIAL EFFUSION WAS DISCOVERED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS AND THE PATIENT WAS SENT TO CARDIOTHORACIC (CT) SURGERY. THE PATIENT WAS SENT TO SURGERY BECAUSE THE PERICARDIAL EFFUSION WAS BUILDING AND GETTING LARGER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DID NOT MENTION WHAT THEY THOUGHT CAUSED THE PERICARDIAL EFFUSION. THE DEVICES USED DURING THE PROCEDURE WERE THERMOCOOL SMARTTOUCH SF CATHETER, CARTO 3 SYSTEM, AND NGEN SYSTEM.

  Patient problems: Cardiac Tamponade

  MAUDE report 24077559 ↗
• InjuryJan 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AND IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION AROUND THE RIGHT VENTRICLE WAS NOTICED. WHILE ABLATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE CATHETER DISPLAYED ON THE CARTO 3 SYSTEM JUMPED AND SLID OUTSIDE OF THE FAST ANATOMICAL MAPPING WHERE IT SHOULD HAVE BEEN. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAM. THE PROCEDURE WAS ABORTED. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE PATIENT WAS MONITORED WITH ULTRASOUND FOR ABOUT 10 MINUTES TO CONFIRM THAT THE PERICARDIAL EFFUSION DID NOT RETURN. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WERE THE ABLATIONS WERE IN THE ANTERIOR RVOT, WHICH IS THINNER. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT IS FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT INSTEAD OF THE RECOVERY ROOM. THE SHEATH AND THE CATHETER WERE EXCHANGED ONCE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED DURING THE PROCEDURE. SIX ABLATIO

  Patient problems: Cardiac Tamponade

  MAUDE report 24024607 ↗
• InjuryJan 8, 2026Patient Device Interaction Problem

  NEAR THE END OF THE CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROPPED, AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS WITH FLUID REMOVAL. THE PATIENT WAS TRANSFERRED TO OPERATING ROOM TO HAVE A PATCH PLACED. THE OUTCOME OF THE EVENT WAS THAT THE PATIENT'S CONDITION IMPROVED. THE PROCEDURE WAS FOR THE PLACEMENT OF A LARIAT DEVICE FOLLOWED BY AN ATRIAL FIBRILLATION ABLATION. INTRACARDIAC ECHO DISPLAYED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS COMPLETED, AND THE AMOUNT FLUID REMOVED WAS UNKNOWN. THE PATIENT WAS STABLE ON TRANSFERRING TO THE OPERATING ROOM TO HAVE A "PATCH PLACED". THE PHYSICIAN RESPONSE WAS THAT THE EFFUSION WAS CAUSED DURING EPICARDIAL ACCESS FOR IMPLANTATION OF THE LARIAT DEVICE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF STAYING OVERNIGHT FOR MONITORING. A NGEN PUMP WAS DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 24007847 ↗
• MalfunctionJan 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND NOISE WAS OBSERVED ON ALL CHANNELS AND NO ECG SIGNALS AVAILABLE TO MONITOR THE PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS NOISE IN THE ECG AFTER CONNECTING THE CATHETER TO THE PATIENT INTERFACE UNIT (PIU). THEY CHANGED THE CABLE BUT NO EFFECT. CHANGED THE CATHETER AND NO FURTHER NOISE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED NOISE ISSUE IS 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 16 DEC 2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE NOISE WAS OBSERVED ON ALL INTRACARDIAC (IC) AND BODY SURFACE (BS) ECG CHANNELS ON BOTH THE CARTO 3 SYSTEM AND RECORDING SYSTEM AND THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THE CATHETER WAS IN THE BODY AT FIRST AND AFTER THEY PULLED IT OUT, THERE WAS STILL NOISE. BASED ON THIS NEW INFORMATION, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954258 ↗
• InjuryDec 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED HYPOTENSION AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS AND EXTENDED HOSPITALIZATION BECAUSE OF PERICARDIOCENTESIS AS WELL AS ADDITIONAL FLUID DRAINING OVERNIGHT AFTER PROCEDURE, AND FOR MONITORING. THE REPORT INDICATED THAT AFTER AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. THERE WERE NO ISSUES WITH THE PATIENT DURING THE PROCEDURE. THE PATIENT BECAME HYPOTENSIVE WHEN THE PATIENT WAS IN POST-OP. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. PHYSICIAN BELIEVES IT WAS AFTER ABLATION AND DURING THE VENTRICULAR ELECTROPHYSIOLOGY (EP) STUDY WHEN PACING OFF ABLATION CATHETER IN VENTRICLE. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF PERICARDIOCENTESIS AS WELL AS ADDITIONAL FLUID DRAINING OVERNIGHT AFTER PROCEDURE, AND FOR MONITORING. THE RELEVANT TESTS/LABORATORY

  Patient problems: Cardiac Tamponade

  MAUDE report 23935452 ↗
• InjuryDec 24, 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 PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. AFTER THE PROCEDURE WAS COMPLETED, THE PHYSICIAN CHECKED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) POST PROCEDURE AND NOTICED A LARGE PERICARDIAL EFFUSION. THEY DID NOT SHOW SYMPTOMS OR DROP IN BLOOD PRESSURE AT THIS POINT. THE PHYSICIAN CONFIRMED THE PERICARDIAL EFFUSION ON X-RAY AS WELL AS ON ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND 600CC OF BLOOD WAS DRAINED. THE PHYSICIAN CONSULTED WITH A SURGEON, AND THEY WERE GOING TO OBSERVE THE PATIENT. THE BLEEDING HAD STOPPED AND THE PATIENT WAS STABLE AND WAS SOON TO BE IN RECOVERY. THE BWI PRODUCTS IN THE BODY AT THE TIME OF THE EVENT WERE A SOUNDSTAR CATHETER, PENTARAY CATHETER, DECANAV CATHETER, AND A THERMOCOOL SMARTTOUCH SF CATHETER. OTHER DEVICES USED DURING THE PROCEDURE WERE THE CARTO 3 SYSTEM AND SMARTABLATE GENERATOR. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURAL COMPLICATION. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PATIENT REQ

  Patient problems: Cardiac Tamponade

  MAUDE report 23886054 ↗
• MalfunctionDec 18, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT CATHETER HAD THE MAGNETIC SENSOR INVERTED. THE CALLER STATES THAT THE IMAGE ON THE CARTO 3 DISPLAY SHOWED THE CATHETER UPSIDE DOWN. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THE CUSTOMER'S REPORTED MAGNETIC SENSOR ISSUE IS 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 (B)(6) 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX AND INTERNAL COMPONENTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846815 ↗
• InjuryDec 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA - (IDVT) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, IT WAS DISCOVERED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THE PATIENT HAD A PERICARDIAL EFFUSION. THERE WERE NO ISSUES DURING THE PROCEDURE, AND THE EFFUSION WAS CONFIRMED WITH ICE AND ECHOCARDIOGRAM (ECHO). THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE PATIENTS LAST KNOWN STATUS IS CURRENTLY STABLE, AND THE MOMENT DOES NOT REQUIRE SURGICAL INTERVENTION. 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 23844390 ↗
• InjuryDec 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED A SIGNIFICANT DROP IN BLOOD PRESSURE. THE PHYSICIAN INSERTED THE ICE CATHETER BUT WAS UNABLE TO VISUALIZE THE PERICARDIAL EFFUSION, SO THEY USED A CHEST PROBE TO CONFIRM. THE PERICARDIAL EFFUSION WAS TREATED WITH PERICARDIOCENTESIS AND THE PATIENT WAS STABILIZED. CARDIOTHORACIC (CT) SURGERY WAS CALLED, AND THE MEDICAL TEAM CHOSE TO DO A FULL MAZE ON THE PATIENT AT THAT TIME. THEY CONFIRMED THAT THEY WOULD BE FINISHING THE ABLATION DURING SURGERY. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT (PERICARDIAL EFFUSION) WAS THAT A SINGLE PERFORATION OCCURRED FOLLOWING ABLATION IN THE ANTERIOR PORTION OF THE RIGHT SUPERIOR PULMONARY VEIN. AFTER THE PROCEDURE, THEY IDENTIFIED THIS ISSUE AFTER LOOKING AT COMPUTED TOMOGRAPHY AND HAD NOT KNOWN THE ISSUE WITH THE PATIENT'S ANATOMY DURING THE PROCEDURE. THE PHYSICIAN IDENTIFIED WHAT HE BELIEVES TO BE A DIVERTICULUM OF THIN TISSUE PROTRUDING FROM THE RSPV (RIGHT SUPERIOR PULMONARY VEIN) AND BELIEVES THIS TO BE THE SITE OF PERFORATION. THE INTERVENTION PROVIDED WAS PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE

  Patient problems: Cardiac Perforation

  MAUDE report 23770802 ↗
• InjuryDec 5, 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 PERICARDIAL EFFUSION WHICH REQUIRED FLUID TO BE WITHDRAWN. THE CASE WENT SMOOTHLY BUT POST CASE, DURING ROUTINE ULTRASOUND, A PERICARDIAL EFFUSION WAS NOTED WHICH REQUIRED APPROXIMATELY 250CC OF FLUID TO BE WITHDRAWN. THE PATIENT WAS STABLE AND NO OTHER INTERVENTION WAS PLANNED AT THAT TIME. BIOSENSE EQUIPMENT WORKED WITHIN SPECIFICATIONS. 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 23725049 ↗

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-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-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-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