ThermoCool SmartTouch D132705Recalls & reported problems

Summary

The FDA's MAUDE database contains 574 adverse event reports that list this exact device (DI 10846835009200), received between Jun 16, 2016 and Aug 20, 2026 — classified as 25 deaths, 362 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (82 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031, P040036); 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 574 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Patient Device Interaction Problem

  Patient problems: Respiratory Failure

  MAUDE report 50359597 ↗
• InjuryAug 19, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a left sided nonischemic ventricular tachycardia ablation with a ThermoCool SmartTouch catheter and the patient experienced a Cardiac Tamponade that required Pericardiocentesis.The patient experienced a Cardiac Tamponade during the transseptal puncture. The Cardiac Tamponade stabilized by the physicians with a puncture. The procedure was successfully completed. It was reported that the ThermoCool SmartTouch catheter was not involved according to the physicians. Additional information was received on 21-Jul-2026 which indicated that the adverse event was discovered post use of Biosense Webster product. Seven radiofrequency ablations were performed outside the Pulmonary Veins. No ablations were performed within the Pulmonary Veins. A BRK Needle was used for the transseptal puncture. The flow setting was set to 0-30W 17ml/min, 30+W 30ml/min, low flow 2ml/min. After, received additional information on 21-Jul-2026 which indicated that the sheath used for transseptal puncture was an Agilis sheath. Ablation was performed prior to noting the Cardiac Tamponade.The adverse event was originally considered non-reportable under the ThermoCool SmartTouch

  Patient problems: Cardiac Tamponade

  MAUDE report 50328216 ↗
• MalfunctionMay 26, 2026Failure to Sense; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED HOLES IN THE PEBAX. TECHNICIAN OPENED A NEW THERMOCOOL SMARTTOUCH CATHETER AND CONNECTED TO A CABLE, THEN TO THE PATIENT INTERFACE UNIT (PIU) AND NOTICED SENSOR ERROR (CODE 106). THEY CHANGED CONNECTING CABLE; HOWEVER, SAME ERROR. THEN THEY RESTARTED COMPLETE CARTO SYSTEM AND RECONNECTED CABLES; HOWEVER, THE SAME ERROR WAS NOTICED. CHANGED TO A NEW THERMOCOOL SMARTTOUCH CATHETER. PROBLEM SOLVED AND CONTINUED THE PROCEDURE. COMPLETED PROCEDURE SUCCESSFULLY. NO SIGNIFICANT DELAY. NO PATIENT OR USER HARM. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 04-MAY-2026, OBSERVED HOLES IN THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF HOLES IN THE PEBAX ON 04-MAY-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25295774 ↗
• MalfunctionApr 24, 2026Insufficient Cooling

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCHCATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN ATTEMPTING TO COME ON ABLATION, THE SMARTABLATE® GENERATOR IMMEDIATELY BEEPED AND DISPLAYED A "CATHETER TEMPERATURE ABOVE MAXIMUM" ERROR MESSAGE. THE CALLER NOTED THAT THE MAXIMUM TEMPERATURE WAS SET TO 40 DEGREES ON THE SMARTABLATE® GENERATOR. THE THERMOCOOL SMARTTOUCH¿ CATHETER CABLE CONNECTIONS WERE RE-SEATED WITHOUT RESOLUTION. THE THERMOCOOL SMARTTOUCH¿ CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED HIGH TEMPERATURE 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 7-APR-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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983590 ↗
• InjuryMar 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, THE PATIENT EXPERIENCED AV BLOCK TREATED WITH PERMANENT PACEMAKER PLACEMENT. THE REPORT INDICATED THAT AFTER ONE ABLATION WITH PULSED FIELD ABLATION (PFA) (SMARTTOUCH + CARDIOFOCUS PFA GENERATOR) FAR FROM THE GUIDANCE SYSTEM, AN AV BLOCK IS FORMED. IT IS POSSIBLE THAT THE PULSE (PARTIALLY) WAS EMITTED BY THE PROXIMAL SHAFT ELECTRODES OF THE ABLATION CATHETER. THESE SHAFT ELECTRODES WERE PROBABLY LOCATED NEAR THE GUIDANCE SYSTEM IN THE LEFT VENTRICLE (LV) SEPTUM. THE EVENT OCCURRED FOLLOWING RETROGRADE LV ACCESS WITH THERMOCOOL SMARTTOUCH ABLATION CATHETER FOR A PVC PROCEDURE. A PERMANENT PACEMAKER WAS PLACED IMMEDIATELY AFTER DETECTION OF AV BLOCK. ALTHOUGH IT IS POSSIBLE THAT THE AV BLOCK WILL RECOVER AFTER AN HOUR, THE HOSPITAL DECIDED TO PLACE A PACEMAKER IMMEDIATELY. THE PATIENT WAS STABLE AND DID NOT REQUIRE EXTENDED HOSPITALIZATION.

  Patient problems: Heart Block

  MAUDE report 24614889 ↗
• MalfunctionMar 12, 2026Insufficient Cooling; Improper or Incorrect Procedure or Method; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH HAD AN IRRIGATION ISSUE DURING USE ON THE PATIENT. IT WAS REPORTED BY THE CUSTOMER THAT THE THERMOCOOL SMARTTOUCH CATHETER STOPPED IRRIGATING AND WHEN ATTEMPTING TO ABLATE THE FIRST TIME, AN ERROR APPEARED ON THE GENERATOR INDICATING "HIGH HEAT," (CODE UNKNOWN). IT WAS THEN DISCOVERED THAT THE IRRIGATION TUBING HAD BECOME DISCONNECTED. ATTEMPTED FLUSHING WAS UNSUCCESSFUL, IRRIGATION PORTS WERE OCCLUDED. THE CATHETER WAS EXCHANGED FOR A THERMOCOOL SMARTTOUCH SF (STSF) CATHETER TO RESOLVE AND CONTINUE THE CASE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586205 ↗
• MalfunctionFeb 27, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PHYSICIAN COULDN'T GET THE CATHETER OUT OF THE SHEATH EASILY. WHEN THEY CHECKED THE ABLATION CATHETER, THERE WAS A SMALL BUMP ON THE CATHETER CLOSE TO THE ELECTRODES. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE EVENT OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477447 ↗
• MalfunctionJan 16, 2026Insufficient Cooling; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. DURING THE PROCEDURE, WHEN STARTING THE ABLATION THE GENERATOR SHOWED "POWER CONTROL" BECAUSE THE TEMPERATURE WAS OVER THE LIMIT. IN THE CATHETER SENSOR, THE MEDICAL TEAM IDENTIFIED BLOOD. THERE WAS NO DIFFICULTY IN MANEUVERING OR WITHDRAWING THE CATHETER DURING USE ON THE PATIENT. NO PHYSICAL DAMAGES WERE NOTED WITH THE CATHETER AS WELL. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED TO COMPLETION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091575 ↗
• MalfunctionJan 9, 2026Signal Artifact/Noise; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND ERROR CODE 7: LEAKAGE CURRENT HAS BEEN DETECTED ERROR OCCURRED. TROUBLESHOOTING THE ISSUE WAS PERFORMED BY DISCONNECTING THE CABLES FROM PATIENT INTERFACE UNIT AND REPLACING THE CATHETER CABLE AND THE CATHETER, BUT THE ISSUE DID NOT RESOLVE. THE CURRENT LEAKAGE RESULTED IN DISTURBANCE IN ELECTROCARDIOGRAM (ECG) BUT DID NOT AFFECT THE PROCEDURE. THE ERROR WAS ACCOMPANIED BY LOSS OF BODY SURFACE ECG SIGNALS ON THE CARTO SYSTEM AND ABBOTT RECORDING SYSTEM. THE PHYSICIAN HAD A SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CATHETER WAS NOT INSIDE THE PATIENT¿S BODY DURING SIGNAL INTERFERENCE. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION AND 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 24030413 ↗
• MalfunctionDec 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY, IT WAS REPORTED THAT THE CATHETER FORCE SENSOR ERROR OCCURRED. THE CABLE WAS REPLACED, BUT THE PROBLEM WAS NOT RESOLVED. A NEW CATHETER WAS INSERTED. THE PROCEDURE WAS NOT DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 02-DEC-2025, OBSERVED REDDISH MATERIAL AND 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 02-DEC-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901268 ↗
• MalfunctionDec 19, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, WITH A THERMOCOOL SMARTTOUCH CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT, ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, THERMOCOOL SMARTTOUCH CATHETER SHOWED CATHETER SENSOR ERROR MESSAGE. CONNECTION CABLE REPLACEMENT AND REBOOT WERE UNSUCCESSFUL. THE CATHETER WAS REPLACED AND THE PROCEDURE COULD BE PERFORMED SAFE AND SUCCESSFULLY. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS A MAGNETIC SENSOR ERROR. CATHETER COULD NOT BE DISPLAYED IN CARTO 3 SCREEN. REQUESTED IF THE TEMPERATURE SENSOR FAILED AND RESPONSE INDICATED, ¿NO ERROR FOR TEMPERATURE SENSOR¿. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 26-NOV-2025, OBSERVED REDDISH MATERIAL AND 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 26-NOV-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851584 ↗
• InjuryDec 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE WHICH REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TAMPONADE DURING THE PROCEDURE. WHILE ABLATING IN THE LEFT ATRIUM WITH A THERMOCOOL SMARTTOUCH CATHETER, A NURSE REALIZED THAT THE PRESSURE DROPPED. THE CARDIAC ECHO (ECHOCARDIOGRAM) SHOWED PERICARDIAL EFFUSION. THE PHYSICIAN IMMEDIATELY PUNCTURED THE STERNUM TO DRAIN THE BLOOD FROM THE PERICARDIUM AND AFTER STABILIZING THE PATIENT, THE PATIENT WAS SENT TO THE CARDIAC SURGEON TO CLOSE THE HOLE. ACCORDING TO THE PHYSICIAN, THE TRANSEPTAL WAS VERY CHALLENGING AND HAD TO PUNCTURE THREE TIMES BEFORE SUCCESSFULLY GOING FROM RIGHT TO LEFT ATRIUM. THE EFFUSION MIGHT HAVE BEEN A CONSEQUENCE OF A FAILURE IN ONE OF THOSE SYSTEMS AND THIS WILL BE CLARIFIED DURING THE SURGICAL OPERATION. ALL THE CATHETERS USED DURING THE PROCEDURE WERE DISCARDED AND THEREFORE CANNOT BE SENT FOR INVESTIGATION. NO FRAGMENTS WERE GENERATED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROBABLY UNINTENDED ABLATION IN THE LEFT ATRIAL APPENDAGE (LAA).

  Patient problems: Cardiac Tamponade

  MAUDE report 23765225 ↗
• MalfunctionDec 3, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND NO IRRIGATION OCCURRED. IT WAS REPORTED THAT DURING THE THIRD ABLATION, THEY HAD A HUGE INCREASE IN TEMPERATURE DURING ABLATION, GOING ABOVE 50 CELSIUS. THEY DISCONNECTED AND RECONNECTED AND NO CHANGE. THEY REPLACED THE CABLE WITH A NEW ONE AND THERE WAS NO CHANGE. THERE WAS NO CHAR ON THE CATHETER; HOWEVER, THERE WAS NO IRRIGATION. THEY TRIED TO FLUSH WITH A SYRINGE; HOWEVER, IT WAS ¿IMPOSSIBLE¿. A NEW CATHETER SOLVED THE ISSUE. THE SURGERY WAS DELAYED BY FIVE MINUTES. THERE WAS NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION INDICATED THAT THE TEMPERATURE CUT-OFF VALUE WAS EXCEEDED, AND THE SYSTEM STOPPED THE ABLATION WHEN THE CUT-OFF VALUE WAS EXCEEDED. THE SYSTEM CONTINUED TO ABLATE FOR A FRACTION OF A SECOND ABOVE TEMPERATURE CUT OFF VALUE. GENERATOR PARAMETERS: POWER CONTROL, 50°C CUT OFF. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE IS THE CATHETER. THE DEVICE WAS USED IN THE PATIENT. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710173 ↗
• InjurySep 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE UNDER A BWI SPONSORED CLINICAL TRIAL WITH A THERMOCOOL SMARTTOUCH SF CATHETER. PATIENT RECEIVED INDEX CARDIAC ABLATION ON (B)(6) 2025. ON (B)(6) 2025, PATIENT EXPERIENCED ¿PERICARDITIS¿ (ADVERSE EVENT (AE) # 1) CATEGORIZED AS MODERATE AND NOT SERIOUS. RELATIONSHIP TO STUDY DEVICE IS ¿NOT RELATED¿ AND RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS ¿CAUSAL RELATIONSHIP¿. THE OUTCOME IS ¿RECOVERING/RESOLVING.¿ INTERVENTION WAS ¿MEDICATION AND TTE (TRANSTHORACIC ECHOCARDIOGRAPHY).¿ ON (B)(6) 2025, PATIENT EXPERIENCED ¿PARTIAL OCCLUSIVE DEEP VENOUS THROMBOSIS RIGHT LEG¿ (AE# 2) CATEGORIZED AS MODERATE AND NOT SERIOUS. RELATIONSHIP TO STUDY DEVICE IS ¿NOT RELATED¿ AND RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS ¿CAUSAL RELATIONSHIP.¿ THE OUTCOME IS ¿RECOVERING/RESOLVING.¿ INTERVENTION WAS ¿MEDICATION AND DUPLEX ECHO GROIN.¿ ON (B)(6) 2025, PATIENT EXPERIENCED ¿BILATERAL LUNG EMBOLES¿ (AE# 3) CATEGORIZED AS SEVERE AND SERIOUS AS DEFINED BY PROLONGED HOSPITALIZATION. THE PATIENT WAS ADMITTED ON (B)(6) 2025 AND WAS DISCHARGED ON (B)(6) 2025. RELATIONSHIP TO STUDY DEVICE IS ¿NOT RELATED¿ AND RELATIONSHIP TO THE

  Patient problems: Pericarditis; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 23019189 ↗
• MalfunctionAug 18, 2025Low impedance; Device Markings/Labelling Problem; Low impedance; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) AND THE STAFF PULLED A STSF CATHETER FROM THE SHELF AND OPENED THE CATHETER FOR THE PROCEDURE. DURING THE PROCEDURE, THEY NOTICED THAT THE NGEN RECOGNIZED THE CATHETER AS A ST CATHETER. THE REPORTER NOTED THAT IMPEDANCE VALUES WERE ALSO DROPPING WITHOUT EXPLANATION DURING ABLATION. THEY EXCHANGED THE CATHETER AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DURING THE SAME PROCEDURE, THE REPORTER EXAMINED THE CATHETER AND NOTED THAT THE CATHETER WAS A ST CATHETER. THE WRONG CATHETER WAS INSIDE OF A STSF BOX. ADDITIONAL INFORMATION INDICATED THAT THE PACKAGING WAS DISCARDED BEFORE THE ISSUE WAS DISCOVERED. HOWEVER, THERE WERE NO ST BOXES IN THE DISCARD ROOM. THEREFORE, THEY CANNOT PROVIDE LOT NUMBER OR PACKAGE PHOTOS. THE REPORTER SAW THE OUTER BOX REFLECTED STSF DF WHEN PULLED BEFORE CASE. AS FOR THE INNER PACKAGING, THEY COULD NOT SEE FROM CONTROL ROOM, BUT STAFF REPORTED THEY OPENED A STSF CATHETER. IT WAS ALSO REPORTED THAT THE IMPEDANCE CUTOFF WAS NOT EXCEEDED. UPON ABLATION, IMMEDIATELY IMPEDANCE DROPS WOUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835248 ↗
• MalfunctionAug 5, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND DURING RADIOFREQUENCY (RF) ABLATION, THE TEMPERATURE WAS HIGH. CATHETER IRRIGATION HOLES WERE BLOCKED. THE TEMPERATURE CUT-OFF VALUE WAS EXCEEDED, AND THE SYSTEM STOPPED THE ABLATION WHEN THE CUT-OFF VALUE WAS EXCEEDED. THE ABLATION MODE IS TEMPERATURE CONTROLLED, AND THE CUT-OFF IS SET TO THE DEFAULT VALUE OF 55°C. WHEN THE ISSUE WAS ENCOUNTERED, THE TEMPERATURE EXCEEDED 55°C. THE CATHETER WAS REPLACED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE HIGH TEMPERATURE, CUT-OFF EXCEEDED ISSUE IS NOT MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722667 ↗
• MalfunctionJul 9, 2025Device Alarm System; Insufficient Cooling; Obstruction of Flow; Device Alarm System; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND AT THE BEGINNING OF THE ABLATION PHASE AND THEREFORE AT HIGH FLOW, THE CATHETER DID NOT ALLOW ADEQUATE IRRIGATION (HIGH TEMPERATURE ON SMARTABLATE). ONCE THE ABLATOR WAS DISCONNECTED FROM THE STERILE EXTENSION, THE SALINE SOLUTION FROM THE SMARTABLATE TUBING (SAT) TO THE STERILE EXTENSION FLOWED NORMALLY. HOWEVER, AS SOON AS THE CATHETER WAS CONNECTED, THE FLOW WAS BLOCKED AS IF THERE WAS SOME MECHANICAL OBSTRUCTION INSIDE THAT PREVENTED THE FLOW FROM REACHING THE TIP OF THE CATHETER. CHANGING THE STERILE EXTENSION DID NOT SOLVE THE PROBLEM. INSTEAD, CHANGING THE CATHETER RESOLVED THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ERROR ON THE PUMP WAS RELATED TO BUBBLES. SHORTLY AFTER THE START OF EACH RADIOFREQUENCY DELIVERY, THE BUBBLE ERROR APPEARED. THIS WAS LIKELY BECAUSE, AS THE PASSAGE WAS BLOCKED WITHIN THE ABLATOR, EXCESSIVE PRESSURE WAS GENERATED AT THE PUMP LEVEL. INITIALLY, THEY TRIED TO DO AN EXTERNAL WASH TO SEE IF THERE WERE BUBBLES AT THE LEVEL OF THE SAT. THEN, THEY CHANGED THE STERILE EXT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462456 ↗
• MalfunctionJun 24, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER MAPPING AND PERFORMING SOME ABLATION, THE PHYSICIAN STEPPED ON THE NGEN PEDAL AND CATHETER ERROR 273 WAS DISPLAYED ON THE NGEN GENERATOR. THE CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE CUSTOMER'S REPORTED CATHETER ERROR 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 29-MAY-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. 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 22324917 ↗
• InjuryMay 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND SUFFERED A HEART BLOCK AV WHICH REQUIRED PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT AN ADVERSE EVENT OCCURRED TODAY (30-APR-2025), DURING MAPPING OF THE RIGHT ATRIUM. HIS POINTS TAGGED ON THE MAP WITH THE THERMOCOOL SMARTTOUCH CATHETER. ABLATION PERFORMED AT 30W, ALSO 40W. ON VISITAG 9 CHB OCCURRED. THE PHYSICIAN ABLATED THE PATHWAY AT 50W, THEN STOPPED RF AND A PERIOD OF MONITORING BEGAN. THE PATIENT REMAINED IN COMPLETE HEART BLOCK WITH AN ESCAPE RATE OF 55 BPM. THE PATIENT IS BEING MONITORED OVERNIGHT IN THE HOSPITAL. THE PATIENT WAS STABLE WHEN THEY LEFT THE LAB, AND NO TEMPORARY PACEMAKER WAS USED FOR PACING OR PACEMAKER WAS FITTED AS OF TODAY. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE. FAST PATHWAY ABLATED. INTERVENTION PROVIDED WAS STEROID GIVEN AND OVERNIGHT MONITORING. THE OUTCOME OF THE ADVERSE EVENT IS UNKNOWN AT THE TIME, AND THE PATIENT LEFT THE LAB IN A STABLE POSITION. THE PATIENT REQUIRES EXTENDED HOSPITALIZATION OVERNIGHT STAY FOR MONITORING TO SEE IF THE PATIENT RESUMES TO SINU

  Patient problems: Heart Block

  MAUDE report 22080997 ↗
• MalfunctionApr 21, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH AND OBSERVED A FLUSHING ISSUE (DEVICE USED ON PATIENT) ISSUE. SLIGHTLY ELEVATED TEMPERATURES WERE NOTED DURING ABLATION, REACHING APPROXIMATELY 43-45 DEGREES AND TRIGGERING THE TEMPERATURE WARNING ON THE SMARTABLATE GENERATOR. THE PHYSICIAN REMOVED THE CATHETER FROM THE BODY AND INSPECTED THE TIP BUT COULD NOT SEE ANY CHAR BUILD UP. ATTEMPTING TO FLUSH THE CATHETER PROVED DIFFICULT FOR HIM, SUGGESTING SOME PORTS HAD BECOME BLOCKED. PRIOR TO INSERTING THIS THERMOCOOL SMARTTOUCH, THEY WERE ABLE TO SUCCESSFULLY FLUSH THE CATHETER. THIS CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. THE PROCEDURE WAS DELAYED 20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE ISSUE BEGAN DURING USE ON THE PATIENT. CATHETER WAS ABLE TO BE FLUSHED PRIOR TO USE ON PATIENT. TEMPERATURE WARNING WAS NOTED ON THE REMOTE (SET TO 45 DEGREES) DURING ABLATION. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS THAT THEY WIPED THE END OF THE CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874059 ↗
• MalfunctionApr 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODE ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, AND THE CATHETER WAS UNABLE TO BE ZEROED ON THE CARTO 3 SYSTEM. UPON INSPECTION OF THE CATHETER, THE TIP LOOKED LIKE IT HAD SOME BLOOD AND SALINE INSIDE WHERE THE COIL IS LOCATED. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THERE WAS NO DIFFICULTY MANEUVERING THE DEVICE AND NO DAMAGE WAS OBSERVED. NO PATIENT CONSEQUENCES WERE REPORTED. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED FOR ANALYSIS AND REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX WERE DISCOVERED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774135 ↗
• MalfunctionMar 17, 2025Insufficient Cooling; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Sense; Contamination /Decontamination Problem; Insufficient Cooling; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Sense; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT BEFORE STARTING THE ABLATION, THE IMPEDANCE WAS AROUND 200. WHILE ABLATING THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), WE ENCOUNTERED MAGNETIC INTERFERENCE, SUDDEN INCREASE IN FORCE (AROUND 30G), AND SUDDEN INCREASE IN TEMPERATURE (AROUND 40°C). THE CABLE WAS CHANGED AND HEN THE CATHETER WAS CHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED FORCE, MAGNETIC INTERFERENCE AND TEMPERATURE ISSUES ARE 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. 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 COMPROMISE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627905 ↗
• MalfunctionMar 11, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND ERROR WARNINGS ON THE SMART ABLATE SYSTEM INDICATED THAT THE CATHETER TIP TEMPERATURE WAS RISING ABOVE THE THRESHOLD, MEANING, ABLATION WOULD BE STOPPED BY SYSTEM. UPON REMOVAL OF THE CATHETER, AND WHEN FLUSHED, ONLY THREE OF THE PORTS WERE EJECTING WATER. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE HIGH TEMPERATURE ISSUE IS NOT MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570174 ↗
• InjuryFeb 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT RECEIVED REPEAT CARDIAC ABLATION ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED LOW OXYGEN SATURATION (AE#2) CATEGORIZED AS MODERATE AND NOT SERIOUS. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE REPEAT STUDY PROCEDURE IS CAUSAL. THE OUTCOME IS RECOVERED/RESOLVED. INTERVENTION WAS OXYGEN.

  Patient problems: Respiratory Failure

  MAUDE report 21350213 ↗
• InjuryFeb 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT A REPEAT CARDIAC ABLATION PROCEDURE ON (B)(6) 2025 WITH A THERMOCOOL SMARTTOUCH AND THE PATIENT EXPERIENCED PERICARDITIS AND LOW OXYGEN SATURATION WHICH REQUIRED MEDICAL INTERVENTION. ON (B)(6) 2025, PATIENT EXPERIENCED LOW OXYGEN SATURATION (AE#1) CATEGORIZED AS MODERATE AND NOT SERIOUS. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE REPEAT STUDY PROCEDURE IS CAUSAL. THE OUTCOME IS RECOVERED/RESOLVED WITH AN END DATE OF (B)(6)2025. INTERVENTION WAS OXYGEN. ON (B)(6) 2025, PATIENT EXPERIENCED HEMATOMA LEFT WRIST PUNCTURE SITE (AE#2) CATEGORIZED AS MILD AND NOT SERIOUS. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE REPEAT STUDY PROCEDURE IS CAUSAL. THE OUTCOME IS NOT RECOVERED/NOT RESOLVED. INTERVENTION WAS NONE. ON (B)(6) 2025, PATIENT EXPERIENCED PERICARDITIS (AE#3) CATEGORIZED AS MODERATE AND NOT SERIOUS. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE REPEAT STUDY PROCEDURE IS CASUAL. THE OUTCOME IS NOT RECOVERED/NOT RESOLVED. INTERVENTION WAS MEDICATION.

  Patient problems: Pericarditis; Respiratory Failure

  MAUDE report 21349347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031, P040036. 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-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-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-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-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