ThermoCool SF NAV D131503Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10846835009293), received between Jul 24, 2016 and Aug 9, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PREMATURE VENTRICULAR TACHYCARDIA (PVC)/ IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING AN PVC /VENTRICULAR TACHYCARDIA IDIOPATHIC CASE, A PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS DISCOVERED WHEN THEY PERFORMED AN ¿ANGIOGRAM OUT THE CORONARY SINUS¿ AND THEY WATCHED AS PERICARDIAL EFFUSION CONTINUED TO GROW. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS "DRAINING THE FLUID" AND 120 CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE CONTINUED SUCCESSFULLY. THE REPORTER STATED THAT THE CAUSE OF THE PERICARDIAL EFFUSION IS UNCLEAR. ADDITIONAL INFORMATION: THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PROCEDURE. INTERVENTION PROVIDED: THE FLUID WAS REMOVED. PATIENT OUTCOME OF THE ADVERSE EVENT: FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE

  Patient problems: Cardiac Tamponade

  MAUDE report 12292287 ↗
• MalfunctionFeb 2, 2020Crack; Sharp Edges; Crack; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADIOFREQUENCY CATHETER ABLATION (RFCA) PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND ELECTRODE DAMAGE AND THE PEEK HOUSING CRACKED WITH EXPOSED PARTS. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WOULD NOT DEFLECT. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. ON JANUARY 9, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND UPON INITIAL VISUAL INSPECTION IT WAS NOTED THAT THE TIP DOME WAS FLATTENED ON ONE SIDE WITH ROUND AREA PUSHED IN, THE PEEK HOUSING WAS CRACKED OPEN WITH INTERNAL WIRING EXPOSED WITH RING 2 BEING SQUASHED/DENTED, AND SOME PINS WERE FOUND BENT IN THE CONNECTOR. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH SECOND VISUAL ANALYSIS ON JANUAR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9657169 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE ABLATION PHASE THE PHYSICIAN HEARD OR FELT A STEAM POP, THE PATIENT BECAME HYPOTENSIVE AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS THEN TRANSPORTED TO THE OPERATING ROOM (OR) FOR SURGICAL INTERVENTION. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT CONDITION IMPROVED AND WAS REPORTED IN STABLE CONDITION. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE ADVERSE EVENT TO THE BIOSENSE WEBSTER, INC. PRODUCT AND SUGGESTED IT WAS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE COLOR OPTION USED PROSPECTIVELY WAS TIME. THE STEAM POP WAS ASSESSED AS NOT MDR-REPORTABLE. STEAM POP IS NOT CONSIDERED TO BE A DEVICE MALFUNCTION. STEAM POP IS AN EXPECTED PHYSIOLOGICAL PHENOMENON. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 9619829 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE FOR WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE. DURING MAPPING PHASE IN THE RIGHT VENTRICLE WITH THE THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER, PERICARDIAL EFFUSION WAS NOTICED. THE PATIENT'S BLOOD PRESSURE DROPPED, AND PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAM AND X-RAY. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 300CC OF FLUID. EXTENDED HOSPITALIZATION WAS REQUIRED FOR MONITORING FOLLOWING PERICARDIOCENTESIS. THEREAFTER, PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ABLATIONS WERE DELIVERED. NO TRANSSEPTAL WAS PERFORMED AND NO STEAM POP WAS REPORTED. PATIENT HAD FULLY RECOVERED. THE PATIENT'S CONDITION WAS RESOLVED. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS BOTH THE PROCEDURE AND PATIENT CONDITION. IRRIGATED CATHETER FLOW SETTINGS WERE SET AT 2 ML/MIN. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. NO ERROR MESSAGES ON ANY BIOSENSE WEBSTER INC. (BWI) EQUIPMENT WAS REPORTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 9205752 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER THE FEMALE PATIENT SUFFERED ISCHEMIC CEREBROVASCULAR ACCIDENT. DURING THE PROCEDURE THE PATIENT SHOWED NEUROLOGICAL SYMPTOMS AND ISCHEMIC STROKE WAS CONFIRMED BY MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT). NO MEDICAL INTERVENTION WAS PROVIDED BUT EXTENDED HOSPITALIZATION WAS REQUIRED. THE PATIENT¿S CONDITION HAS IMPROVED AND STABLE. ACCORDING TO THE PHYSICIAN¿S OPINION THE EVENT WAS RELATED TO PATIENT¿S UNDERLYING CONDITION. NO BWI PRODUCT MALFUNCTION WAS REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 9158372 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE IN THE LATERAL WALL, A STEAM POP OCCURRED. INTRACARDIAC ECHO (ICE) WAS USED AND NO PERICARDIAL EFFUSION WAS OBSERVED. THE PROCEDURE CONTINUED AND LATER, CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200ML OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. NO OTHER INTERVENTIONS WERE NECESSARY. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE CASE. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PHYSICIAN CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY. THE REPORTED STEAM POP ISSUE IS NOT MDR REPORTABLE SINCE STEAM POP IS NOT CONSIDERED TO BE A DEVICE MALFUNCTION. STEAM POP IS AN EXPECTED PHYSIOLOGICAL PHENOMENON. THIS EVENT IS MDR REPORTABLE FOR THE SERIOUS INJURY.

  Patient problems: Cardiac Tamponade

  MAUDE report 8670089 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, IN HER 70S, UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION) AND CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION). DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DETECTED VIA ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TWICE AND YIELDED 1000 ML OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. ATRIOVENTRICULAR DISSOCIATION OCCURRED AND THE PATIENT ARRESTED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED. AN UNSPECIFIED SURGICAL INTERVENTION WAS PERFORMED. IT WAS DETERMINED THAT A LEFT ATRIAL TEAR OCCURRED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ALTHOUGH UNCONFIRMED, IT WAS ASSUMED BY THE REPORTER THAT THE PATIENT REQUIRED A STAY IN THE INTENSIVE CARE UNIT (ICU) AND SURVIVED. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS NOTED THAT ALTHOUGH THE ADVERSE EVENT OCCURRED DURING ABLATION PHASE, IT WAS NOT DETERMINED IF IT WAS A RESULT OF ABLATION OR CATHETER MANIPULATION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINI

  Patient problems: Cardiac Arrest; Cardiac Tamponade; No Code Available

  MAUDE report 7462169 ↗
• InjurySep 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, A PERICARDIAL EFFUSION WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED 1000 ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED ONE ADDITIONAL DAY OF HOSPITALIZATION FOR MONITORING AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. LAB RESULTS: PROTHROMBIN TIME (PT) 14.2, INTERNATIONAL NORMALIZED RATIO (INR) 1.2, HEMOGLOBIN (HGB) 14.3, HEMATOCRIT (HCT) 42. IT WAS NOTED THAT THE ADVERSE EVENT OCCURRED DURING ABLATION PHASE. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIANS OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS MEDICAL TRANSSEPTAL NEEDLE AND BAYLIS SHEATH. GENERATOR WAS SET ON POWER CONTROL MODE WITH POWER CUT-OFF OF 40 WATTS AND TEMPERATURE CUT-OFF OF 40 DEGREES CELSIUS. THERE IS NO FURTHER INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, OVERALL ABL

  Patient problems: Cardiac Tamponade

  MAUDE report 6883028 ↗
• InjuryJul 24, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 1300CC. PATIENT WAS SENT FOR SURGICAL INTERVENTION. THERE IS NO INFORMATION REGARDING THE PATIENT'S STATUS. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. SHEATH USED WAS AN AGILIS 8.5 FRENCH. GENERATOR SETTINGS INCLUDED POWER AT 40 WATTS (NOT TITRATED) WITH 20 WATTS ON THE POSTERIOR WALL. ALL OTHER PARAMETERS WERE DEFAULT FOR SF CATHETERS. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS 15 MINUTES. LAST ABLATION CYCLE TIME AT THE SITE OF INJURY IS UNKNOWN. IRRIGATED CATHETER FLOW WAS SET AT 8ML/MIN AT 20 WATTS AND 15 ML/MIN AT 40 WATTS. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED IN AN UNKNOWN RANGE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 5818289 ↗

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-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-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-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-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-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