ThermoCool SF NAV D131802Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835009262), received between Dec 14, 2018 and Nov 20, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. THE EFFUSION WAS DETECTED DIRECTLY AFTER THE PROCEDURE. PUNCTION WAS DONE AND PATIENT WAS FINE AFTER LEAVING THE LAB. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 18167485 ↗
• MalfunctionJul 27, 2023Complete Blockage; Coagulation in Device or Device Ingredient; Insufficient Cooling; Device Contamination with Body Fluid; Complete Blockage; Coagulation in Device or Device Ingredient; Insufficient Cooling; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND BLOOD CLOTS/THROMBUS WERE DISCOVERED. DURING AN ATRIAL FLUTTER ABLATION, CATHETER WAS PROPERLY FLUSHED PRIOR TO INSERTION WITH FLOW RUNNING AT 2ML/MIN AS PER THE AUTOMATED SETTINGS. UPON ABLATION, TEMPERATURE WAS RISING AND RF STOPPED. DECISION TO REMOVE CATHETER AND CHECK IRRIGATION. IRRIGATION WAS BLOCKED. CATHETER REPLACED. PATIENT SEEMED TO BE CLOTTING, FEW CLOTS OBSERVED INSIDE THE SHEATHS. THE SURGERY WAS NOT DELAYED AND COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE THROMBUS WAS FOUND WHILE RINSING THE SHEATH WHEN EXCHANGING CATHETERS. THERE WERE NO ERROR MESSAGES OR PRODUCT PROBLEMS. ISSUES RELATED TO TEMPERATURE WERE ENCOUNTERED AS THE FLOW WAS BLOCKED WITHIN THE CATHETER WHILE DELIVERING THE RF. THE TEMPERATURE WAS RISING AND THE RF WAS STOPPED DUE TO HIGH TEMPERATURE. THE NGEN GENERATOR WAS SET TO POWER CONTROL, 35WATTS. TEMP NOTED AROUND 40 DÉGREES. IMPEDANCE 110, 35 WATTS AND BELOW DUE TO HIGH TEMPERATURE. NO ACTIVATED CLOTTING TIME (ACT), PROCEDURE WAS RIGHT SIDED. THE PHYSICIAN CONSIDERED THE AMOUNT OF THROMBUS/CLOT TO BE EXCESSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406270 ↗
• InjuryMar 31, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A MONOMORPHIC VENTRICULAR EXTRASYSTOLE (VES) MAPPING AND ABLATING PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. AFTER MAPPING THE RIGHT VENTRICULAR OUTFLOW TRACT, THE CARDIAC TAMPONADE WAS NOTICED AND PERICARDIOCENTESIS WAS PERFORMED. AT THAT POINT, THE PROCEDURE WAS CANCELLED. AFTER DRAINING THE EFFUSION FROM THE PERICARDIUM, THE PATIENT WAS IN STABLE CONDITION AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING. DUE TO THE NECESSARY DRAINAGE OF THE PERICARDIAL EFFUSION, THE PATIENT HAD TO STAY IN THE HOSPITAL FOR SOME TIME. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE AND PATIENT CONDITION RELATED. A MONOMORPHIC VES MAPPING AND ABLATION WAS PLANNED, AND THE VENTRICLE WAS PERFORATED. FORCE VISUALIZATION FEATURES: GRAPH, DASHBOARD, VECTOR AND VISITAG. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. AN IRRIGATED CATHETER WAS USED IN THE EVENT WITH FLOW SETTINGS OF STSF LOW 2 HIGH 8 ML AND THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO TRANSS

  Patient problems: Cardiac Tamponade

  MAUDE report 11594021 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. MEDICATION (ANTIBIOSIS) WAS ADMINISTERED. REMAINDER OF THE PROCEDURE WAS ABORTED. THERE¿S NO INDICATION THAT EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE ADVERSE EVENT TO THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED AS IT WAS A RETROGRADE ACCESS. ABLATION WAS PERFORMED PRIOR TO THE ADVERSE EVENT AT 50 WATTS FOR 10 SECONDS. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. IT IS NOT CLEAR AT WHAT STAGE OF THE PROCEDURE THE ADVERSE EVENT OCCURRED; HOWEVER, IT IS MOST LIKELY IT OCCURRED DURING THE ABLATION PHASE. NO ERROR MESSAGES WERE OBSERVED IN ANY BWI EQUIPMENT. THE FLOW SETTING WAS AT 15ML/MIN. THE FORCE VISUALIZATION FEATURES USED DUR

  Patient problems: Cardiac Tamponade

  MAUDE report 9682239 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A NON-ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A THERMOCOOL SF NAV (SF) CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THE PROCEDURE WAS FOR MONOMORPHIC PREMATURE VENTRICULAR CONTRACTIONS (PVC) IN THE RIGHT VENTRICULAR OUTFLOW TRACT. A LOCAL ACTIVATION TIME MAP WAS CREATED. AFTER DEFINING THE EARLIEST LOCATION OF THE PVC, ABLATION WAS STARTED. ABLATION WAS PERFORMED WITH 30W, THEN WITH 40W. AFTER THE ABLATION WAS STOPPED BY THE PHYSICIAN, HE NOTICED A DROP IN THE BLOOD PRESSURE OF THE PATIENT. IMMEDIATELY, AN ULTRASOUND WAS PERFORMED, AND A CARDIAC TAMPONADE WAS NOTED. THE ELECTROPHYSIOLOGICAL PROCEDURE WAS STOPPED TO STABILIZE THE PATIENT. PERICARDIOCENTESIS WAS PERFORMED AND STERNOTOMY. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND REQUIRED EXTENDED HOSPITALIZATION. THE EXACT TIME OF INJURY IS UNKNOWN. HOWEVER IT IS BELIEVED TO HAVE EITHER HAPPENED DURING THE MAPPING OR ABLATION PHASE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THE CATHETER WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE. GENERATOR SETTINGS WERE SET FOR IMPEDANCE CUTOFF AT 250 OHMS, TEM

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 9492341 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, PROBABLY DURING MAPPING PHASE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF BLOOD FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED.IT IS NOTED THAT THE EVENT COULD POSSIBLY BE DUE TO PATIENT MOVING ON THE TABLE DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE GENERATOR WAS USED IN POWER CONTROL MODE. NO ABLATION WAS APPLIED PRIOR TO THE ADVERSE EVENT. BEFOREHAND, ABLATION TOOK PLACE WITH 30 WATTS, IMPEDANCE BELOW 200 OHMS, AND TEMPERATURE WITHIN NORMAL RANGE. THE CATHETER IRRIGATION WAS SET AT 8ML/MIN UP TO 30 WATTS AND 15ML/MIN ABOVE 30 WATTS. THE GENERATOR SHOWED IMPEDANCE ABOVE MAX CLOSE TO THE PULMONARY ARTERY. THE PARAMETERS USED FOR STABILITY WITH VISITAG MODULE WAS 3MM, 3 SECONDS. NO

  Patient problems: Cardiac Tamponade

  MAUDE report 8166423 ↗

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-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-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-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-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-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