ThermoCool SF NAV D131803Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835009279), received between Jun 16, 2016 and Oct 25, 2019 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE AND DEATH. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK NEEDLE. ABLATION WAS PERFORMED BEFORE THE EFFUSION WAS DISCOVERED. PERICARDIOCENTESIS WAS PERFORMED. PATIENT SUFFERED OUTCOME OF DEATH LATER THAT EVENING. THE PHYSICIAN¿S OPINION IS THAT THE OUTCOME IS RELATED TO THE PATIENT CONDITION AND PROCEDURE. NO STEAM POP WAS REPORTED. NO ERROR MESSAGES ON AND BIOSENSE WEBSTER INC. (BWI) EQUIPMENT WERE REPORTED.

  Patient problems: Death; Pericardial Effusion

  MAUDE report 9236743 ↗
• DeathApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) ASYSTOLE (REQUIRING REANIMATION TREATMENT) AND DEATH. DURING THE PROCEDURE IN ABLATION PHASE WHEN REPOSITIONING THE THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER IN THE RIGHT VENTRICLE OUTFLOW TRACT (RVOT), CARDIAC PERFORATION OCCURRED. PATIENT¿S BLOOD PRESSURE WAS NOT SABLE; THEREFORE, PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. PERICARDIOCENTESIS COULD NOT STABILIZE PATIENT¿S BLOOD PRESSURE. THE PATIENT WENT INTO ASYSTOLE, REANIMATION PHASE WAS PERFORMED FOR OVER 90 MINUTES WITHOUT SUCCESS AND THE PATIENT WAS TRANSPORTED. THE ABLATION PROCEDURE WAS DELAYED TO THE ADVERSE EVENT AND NOT COMPLETED. SUBSEQUENTLY THE EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE DEATH IS THAT IT WAS CAUSED BY THE PERFORATION AND CARDIAC TAMPONADE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK-1 TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE CATHETER IRRIGATION WAS SET IN LOW FLOW AT 2 ML/MIN AND AT HIGH

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Death

  MAUDE report 8521339 ↗
• MalfunctionJun 16, 2016Device Operates Differently Than Expected; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SF NAVIGATIONAL CATHETER. INITIALLY THERE WAS A LOSS OF SIGNALS IN THE ENDOCAVITARY LINE DURING THE PROCEDURE. THE PROBLEM WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS ISSUE WAS ASSESSED AS NOT REPORTABLE AS THE PATIENT'S HEART RHYTHM WAS STILL VISIBLE TO THE OPERATOR. THE RISK TO THE PATIENT WAS LOW. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE PRODUCT FOR ANALYSIS AND DISCOVERED ON MAY 19, 2016 THAT THE PEEK HOUSING WAS BENT AND SQUASHED BETWEEN RINGS #2 AND #3 CAUSING RING #2 TO HAVE A ROUGH AREA WHERE THE POLYURETHANE (PU) MARGIN IS NO LONGER ON THE PROXIMAL SIDE. THE PU WAS PEELING BETWEEN RING #2 AND #3. THE ST. JUDE AGILIS GAINE SHEATH WAS USED. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH. THIS CATHETER WAS NOT PRE-SHAPED. IT WAS NOT KNOWN IF THIS CATHETER CONDITION WAS OBSERVED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT CONSEQUENCE. BOTH THE PU PEELING AND THE ROUGH SURFACE ARE ASSESSED AS REPORTABLE MALFUNCTIONS. THE PEELING PU EXPOSES THE INTERNAL PA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5730937 ↗

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-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-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-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