THERMOCOOL SMARTTOUCH SF D134803Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835010169), received between May 3, 2018 and Oct 2, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “High Sensing Threshold” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6)) UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FLUTTER (AFL) WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED BY THE CALLER WHILE ABLATING IN THE LEFT ATRIUM THE CATHETER WAS NOT ABLE TO MOVE FREELY AND THE ULTRASOUND CATHETER SHOWED A PERICARDIAL EFFUSION THAT MEASURED AT 1.5 CM. THE PATIENT IS STABLE. THE PHYSICIAN FEELS THE ABLATION CATHETER MAY HAVE CAUSED THE PERICARDIAL EFFUSION. THE CALLER STATES THE PERICARDIOCENTESIS WAS PERFORMED. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS DURING ABLATION PHASE. THE PHYSICIAN¿S OPINION IS THAT THE CAUSE OF THIS ADVERSE EVENT IS PATIENT¿S CONDITION. THE PATIENT HAD FULLY RECOVERED AFTER EXTENDED HOSPITALIZATION (LENGTH OF STAY IS UNKNOWN). TRANSSEPTAL WAS PERFORMED (DEVICE UNKNOWN). PRIOR TO NOTING THE EFFUSION ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. IRRIGATION SETTING WAS 15ML/MIN. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. GRAPH, DASHBOARD, VECTOR AND VISITAG WERE USED FOR FORCE VISUALIZATION. THE VISITAG

  Patient problems: Cardiac Tamponade

  MAUDE report 10623836 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A HEART BLOCK AV WHICH REQUIRED A PERMANENT IMPLANTABLE PACEMAKER. DURING THE PROCEDURE, A JUNCTIONAL ESCAPE RHYTHM WAS OBSERVED AND A HEART BLOCK WAS DISCOVERED. THE TEMPORARY PACEMAKER WAS SET. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND A 24 HOUR HOLD HAD BEEN PUT ON TO SEE IF THE NODE WOULD REINITIATE ACTIVITY. THE PERMANENT PACEMAKER WAS TO BE SET IF NO ACTIVITY WAS SEEN DURING THE 24 HOUR HOLD. THE PERMANENT PACEMAKER WAS IMPLANTED THE NEXT DAY. THE PATIENT REQUIRED EXTENDED HOSPITAL STAY AND PERMANENT DAMAGE WAS SUSTAINED BY THE AV NODE REQUIRING A PERMANENT IMPLANTABLE PACEMAKER. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE WHILE ABLATING A FLUTTER IN THE LEFT ATRIUM NEAR THE LEFT ATRIAL SEPTUM.

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 9236778 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, WHILE POSITIONING THE SOUNDSTAR CATHETER, A SMALL PERICARDIAL EFFUSION WAS DETECTED VIA ULTRASOUND. THE PROCEDURE CONTINUED. TRANSSEPTAL PUNCTURE WAS PERFORMED X 2 WITH AN UNSPECIFIED TRANSSEPTAL NEEDLE. THE SMARTTOUCH SF CATHETER AND THE LASSO CATHETER WERE POSITIONED IN THE LEFT ATRIUM. PERICARDIAL EFFUSION WAS NOTED TO HAVE INCREASED. REMAINDER OF THE PROCEDURE WAS ABORTED. CATHETERS WERE REMOVED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. PATIENT UNDERWENT A SURGICAL INTERVENTION. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

  Patient problems: Cardiac Tamponade; Not Applicable

  MAUDE report 7488731 ↗
• InjuryMay 3, 2018High Sensing Threshold; Impedance Problem; High Sensing Threshold; Impedance Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC ARREST (REQUIRING DEFIBRILLATION) AND A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION). PRE-PROCEDURE, THE PATIENT WAS ADMITTED TO THE FACILITY POST-MYOCARDIAL INFARCTION AND VENTRICULAR TACHYCARDIA. POST-ADMISSION, THE PATIENT WAS INTUBATED. AT AN UNSPECIFIED POINT, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION AND RECEIVED GREATER THAN 30 DEFIBRILLATOR SHOCKS (ICD AND EXTERNAL). DURING THE PROCEDURE, THERE WERE 2 ACUTE INCREASES IN IMPEDANCE AND HIGH FORCE READINGS ON THE FORCE GRAPH (BUT NOT ON THE DASHBOARD). AFTER APPROXIMATELY 60 MINUTES OF ABLATION, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DETECTED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. PATIENT REQUIRED AN OPEN CHEST SURGICAL INTERVENTION TO REPAIR A TEAR IN THE CARDIAC TISSUE. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. PHYSICIAN INDICATED THAT THE ADVERSE EVENT WAS SECONDARY TO CATHETER MANIPULATION

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Not Applicable

  MAUDE report 7485271 ↗

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-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-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-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