THERMOCOOL SMARTTOUCH SFRecalls & reported problems across all models

We found 8 models of THERMOCOOL SMARTTOUCH SF by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 6,238 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2016 and Sep 28, 2026 — classified as 268 deaths, 4,034 injuries, 1,936 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2,816 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

THERMOCOOL SMARTTOUCH SF recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 7, 2022Open, Classified

   Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

   Z-0169-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported THERMOCOOL SMARTTOUCH SF problems

THERMOCOOL SMARTTOUCH SF models

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

• THERMOCOOL SMARTTOUCH SF D134805

  Cardiac ablation percutaneous catheter
  1 recall176 deaths4,106 reports
• THERMOCOOL SMARTTOUCH SF D134804

  Cardiac ablation percutaneous catheter
  44 deaths784 reports
• THERMOCOOL SMARTTOUCH SF D134801

  Cardiac ablation percutaneous catheter
  15 deaths608 reports
• THERMOCOOL SMARTTOUCH SF D134702

  Cardiac ablation percutaneous catheter
  19 deaths366 reports
• THERMOCOOL SMARTTOUCH SF D134701

  Cardiac ablation percutaneous catheter
  11 deaths278 reports
• THERMOCOOL SMARTTOUCH SF D134703

  Cardiac ablation percutaneous catheter
  3 deaths72 reports
• THERMOCOOL SMARTTOUCH SF D134802

  Cardiac ablation percutaneous catheter
  20 reports
• THERMOCOOL SMARTTOUCH SF D134803

  Cardiac ablation percutaneous catheter
  4 reports

Recent THERMOCOOL SMARTTOUCH SF adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 25, 2026Patient Device Interaction Problem

  Patient problems: Ischemic Heart Disease; Stenosis

  MAUDE report 50905987 ↗
• MalfunctionSep 25, 2026Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905777 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904050 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50891896 ↗
• InjurySep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Patient Device Interaction Problem

  It was reported that a patient underwent an ablation procedure with two (2) THERMOCOOL SMARTTOUCH SF catheters and the patient experienced a cerebrovascular accident (CVA) which required hospitalization and an interventional radiology procedure.It was initially reported there were no errors on the system, and force values were normal. Then the Smartablate Generator displayed ¿HI¿ force reading when ablation was applied. The catheter was re-zeroed, same problem occurred, replaced the cable but same problem, replaced catheter and the issue resolved issue.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.Hours after procedure, the patient became confused and irritable with mental status change. An MRI was done which confirmed the CVA/stroke. Interventional radiologist did an unknown procedure. Patient required extended hospitalization as a result of the event. Patient's vision has been affected as the patient reported blindness as a result of the CVA.The physician¿s opinion on the cause of this adverse event is that it is not related to

  Patient problems: Stroke/CVA

  MAUDE report 50863493 ↗
• MalfunctionSep 18, 2026Communication or Transmission Problem; Impedance Problem; Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812808 ↗
• InjurySep 3, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 50576868 ↗
• InjurySep 2, 2026Patient Device Interaction Problem

  Patient problems: Heart Block

  MAUDE report 50573398 ↗
• InjurySep 1, 2026Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation with a THERMOCOOL SMARTTOUCH SF catheter and the patient experienced pericardial effusion that required pericardiocentesis and surgical intervention.Force sensor error happened when procedure was about to complete. The user was informed about absence of force sensing due to the sensor error, but the user decided to continue as the procedure since they were almost finished.An echocardiography was performed post-procedure and a pericardial effusion was found in patient. Pericardiocentesis was performed immediately and the patient was sent under intensive care at the ward. The patient needed a cardiothoracic surgeon to fix the tamponade and therefore required extended hospitalization.The cause of pericardial effusion could not be determined, whether it was related to use after force sensor error or was due to extensive point-by-point AF (atrial fibrillation) ablation performed during procedure.

  Patient problems: Cardiac Tamponade

  MAUDE report 50547952 ↗
• InjuryAug 31, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a THERMOCOOL SMARTTOUCH SF Catheter and the patient experienced cardiac perforation which required pericardiocentesis and surgical intervention.During the procedure, 17 ablations were performed outside of the pulmonary veins. While ablating in the right ventricular outflow tract, the patient¿s blood pressure dropped. A pericardial effusion was diagnosed via intracardiac echocardiography (ICE). Pericardiocentesis was performed by the physician. The patient was stable and was transferred to the operating room for further surgical intervention. Patient has fully recovered.Physician¿s opinion on the cause of the event is that there was a perforation during ablation or catheter manipulation.

  Patient problems: Cardiac Perforation

  MAUDE report 50528618 ↗
• MalfunctionAug 31, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525633 ↗
• InjuryAug 27, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with an THERMOCOOL SMARTTOUCH SF Catheter and the patient experienced cardiac tamponade which required pericardiocentesis. During the ablation phase, while using Biosense Webster product, the left pulmonary vein (PV) was isolated however the right PV was not yet isolated. After pacing was performed to check the block, a decrease in blood pressure was observed. Blood pressure was 69/48. Echocardiography was performed and pericardial effusion was observed. Pericardial drainage was performed and the blood pressure stabilized to 129/90. The ablation was discontinued, and the patient was transported to another hospital for extended hospitalization. Physician's assessment of health hazard is non-serious (moderate/mild). The cause of the event is unknown, but the physician does not believe the event was caused by the product. There were no abnormalities observed prior to or during product use.

  Patient problems: Cardiac Tamponade

  MAUDE report 50466591 ↗
• 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 ↗
• InjuryAug 26, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an ablation procedure with a THERMOCOOL SMARTTOUCH SF catheter and experienced heart block and cardiac tamponade which required pericardiocentesis.During ablation to the slow pathway, transient atrioventricular (AV) block occurred. After the patient left the room, cardiac tamponade was identified. Drainage was performed and 300mL was drained and the patient condition improved. No additional intervention was required for the AV block, as AV conduction recovered following pericardial drainage. The patient required extension of hospitalization.Physician¿s opinion regarding the cause of the AV block and cardiac tamponade is they are not entirely sure, but it may have been related to edema or thermal injury affecting the AV node. The ablation site was more than 20 mm away from the His bundle. Procedural activated clotting time was around 350 seconds. Transseptal puncture was not performed. About three to four radiofrequency ablations to slow pathway, outside the pulmonary veins, were performed. There was no evidence of steam pop. Correct catheter settings were selected on the generator. There were no issues with flow rate change at the start of a

  Patient problems: Cardiac Tamponade; Heart Block

  MAUDE report 50444909 ↗

Other Biosense Webster Inc products

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• QDOT MICRO7 models · 1,418 reports
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• PENTARAY NAV12 models · 842 reports · 4 recalls
• OCTARAY Mapping Catheter6 models · 407 reports
• CARTO VIZIGO2 models · 349 reports
• SOUNDSTAR6 models · 260 reports
• PREFACE3 models · 193 reports