ThermoCool SmartTouchRecalls & reported problems across all models

We found 7 models of ThermoCool SmartTouch by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 1,163 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2015 and Sep 29, 2026 — classified as 51 deaths, 719 injuries, 391 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (200 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ThermoCool SmartTouch problems

ThermoCool SmartTouch models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ThermoCool SmartTouch D132705

  Cardiac ablation percutaneous catheter
  25 deaths574 reports
• ThermoCool SmartTouch D133602

  Cardiac ablation percutaneous catheter
  8 deaths225 reports
• ThermoCool SmartTouch D133601

  Cardiac ablation percutaneous catheter
  10 deaths162 reports
• ThermoCool SmartTouch D132704

  Cardiac ablation percutaneous catheter
  7 deaths121 reports
• ThermoCool SmartTouch D132701

  Cardiac ablation percutaneous catheter
  51 reports
• ThermoCool SmartTouch D133603

  Cardiac ablation percutaneous catheter
  1 death23 reports
• ThermoCool SmartTouch D132702

  Cardiac ablation percutaneous catheter
  7 reports

Recent ThermoCool SmartTouch adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50941074 ↗
• 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 ↗
• MalfunctionJun 15, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND THERE WAS SIGNAL INTERFERENCE WAS OBSERVED ON ALL CHANNELS. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN CONNECTING THE ST CATHETER, BS ECG AND OTHER SIGNALS (INCLUDING THE ST SIGNALS) WERE VERY DISTORTED. CHANGING CABLE DIDN'T SOLVE THE ISSUE. CHANGING CATHETER DID. THERE WAS NO PATIENT CONSEQUENCE. ON 18-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING SIGNAL INTERFERENCE WAS OBSERVED ON ALL CHANNELS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM, THEY HAD TO REMOVE THE CATHETER. BASED ON THE INFORMATION RECEIVED INDICATING THERE WERE NO SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM DURING THE PROCEDURE, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499457 ↗
• 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 ↗
• MalfunctionMay 12, 2026Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, THE CATHETER RECEIVED A SENSOR ERROR 105. THE CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151014 ↗
• 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 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. DURING THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION CAUSING CARDIAC TAMPONADE. THE BLOOD WAS DRAINED AND THE PATIENT WAS STABILIZED. PATIENT WENT TO ICU (INTENSIVE CARE UNIT) AND WAS STABLE 2 HOURS AFTER THE PROCEDURE. THE PHYSICIAN SUSPECTED THAT THE CARDIAC TAMPONADE MAY HAVE OCCURRED DURING THE TRANSSEPTAL PUNCTURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 24928049 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED A STROKE THAT REQUIRED THROMBECTOMY AND PROLONGED HOSPITALIZATION. AFTER THE ABLATION PROCEDURE WITH THE CARTO NAVIGATION SYSTEM (APPROX. 30 MIN AFTER WAKING UP FROM ANESTHESIA), THE PATIENT WAS IN THE RECOVERY UNIT AND SHOWED SIGNS COMPATIBLE WITH A STROKE. THE PATIENT COULD NOT MOVE HIS RIGHT ARM OR SPEAK CLEARLY. A CT SCAN WAS QUICKLY PERFORMED TO VERIFY WHETHER IT WAS A THROMBUS OR A HEMORRHAGE. IT WAS CONFIRMED THAT THERE WAS A THROMBUS AND A THROMBECTOMY WAS PERFORMED, THROUGH WHICH THE THROMBUS WAS REMOVED. THE PATIENT WAS RECOVERING. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION.

  Patient problems: Stroke/CVA

  MAUDE report 24918186 ↗
• InjuryApr 15, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED EXTENDED HOSPITALIZATION. IT WAS REPORTED THAT THE PROCEDURE WAS "LINEAR" WITHOUT COMPLICATIONS OR EVENTS TO HIGHLIGHT. HOWEVER, AFTER A FEW HOURS OF FINISHING THE PROCEDURE AND WHEN THE PATIENT WAS NO LONGER IN THE ROOM, HE BEGAN TO FEEL ILL AND WAS TACHYCARDIC. THEY DID AN ULTRASOUND TO CHECK AND THEY SAW AN EFFUSION, WHICH COULD BE DUE TO A TAMPONADE THAT OCCURRED DURING THE PROCEDURE. THE PATIENT WAS STABLE AND DID NOT REQUIRE SURGERY; HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED. FOLLOW UP WAS REQUESTED TO DETERMINE IF THERE WAS ANY PRODUCT MALFUNCTION AS IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON "FOR AN ATRIAL FIBRILLATION NETWORK WITH THE CARTO 3 SYSTEM AND WITH BIOSENSE WEBSTER MATERIAL HAD BECOME BLOCKED."

  Patient problems: Cardiac Tamponade

  MAUDE report 24881653 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO PVI (PULMONARY VEIN ISOLATION) ABLATION WITH A THERMOCOOL SMARTTOUCH AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. IT WAS REPORTED THAT THE PROCEDURE WENT QUITE WELL AT THE BEGINNING. FOR THE MEDICAL TEAM, "IT SEEMED LIKE A BIT OF STRUGGLING" GOING TO THE LA (LEFT ATRIUM) AFTER THE TRANSSEPTAL PUNCTURE (1 PUNCTURE TWO CATHETERS THROUGH THE SAME HOLE). AFTER SOME SOME MINUTES THE PHYSICIAN MANAGED TO GO TO THE LA WITH BOTH CATHETERS. EVERYTHING SEEMED FINE AND AFTER THE MAP THE ABLATION STARTED AT THE POSITIONS WHERE THE VEINS WERE STILL OPEN. AFTER 11 ABLATION POINTS, THE NURSES AND PHYSICIAN RECOGNIZED A DROP IN THE BLOOD PRESSURE AND DID ULTRASOUND (TTE - TRANSTHORACIC ECHOCARDIOGRAM) WHICH SHOWED A TAMPONADE. EPICARDIAL PUNCTURE WAS PERFORMED IMMEDIATELY AND MEDICATION AGAINST HEPARIN (HAD BEEN GIVEN BEFORE IN NORMAL WORKFLOW) WAS GIVEN. THE BLOOD WHICH WAS SUCKED OUT OF THE EPICARDIAL VOLUME WAS REINTRODUCED. SINCE THE HOLE DIDN¿T CLOSE BY ITSELF, A HEART SURGEON HAD TO COME TO OPEN THE CHEST AND CLOSE THE HOLES. SHE FOUND 2 HOLES TO CLOSE WHICH WHERE AT THE ROOF OF THE

  Patient problems: Cardiac Perforation

  MAUDE report 24734959 ↗
• 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 ↗
• InjuryFeb 23, 2026Patient Device Interaction Problem

  AFTER ATRIAL FIBRILLATION + ATYPICAL FLUTTER ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, THE PATIENT EXPERIENCED CARDIAC ARREST AND CARDIAC TAMPONADE TREATED WITH SURGERY TO CLOSE THE TAMPONADE. THE REPORT INDICATED THAT AFTER THEY FINISH ATRIAL FIBRILLATION + ATYPICAL FLUTTER ABLATION PROCEDURE, THE PATIENT SUFFERED A CARDIAC ARREST IN THE RECOVERY ROOM. AM ECHOCARDIOGRAPH DISCOVERED THAT THE PATIENT HAD CARDIAC TAMPONADE. THE INTERVENTIONAL HEMODYNAMICS TEAM PERFORMED SURGERY PROCEDURE TO CLOSE THE TAMPONADE, AND AS OF TWO HOURS AFTER ITS COMPLETION THE PATIENT REMAINS HEMODYNAMICALLY STABLE. AFTER SURGERY, THE PATIENT IS STABLE. 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 Arrest; Cardiac Perforation

  MAUDE report 24424778 ↗

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