ThermoCool SF D131603Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835009330), received between Nov 21, 2018 and Jul 16, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJul 16, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF UNI-DIRECTIONAL CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED CRACKED/BROKEN PEEK HOUSING, EXPOSED WIRING, AND A BROKEN PULLER WIRE INSIDE OF THE HANDLE. DURING THE PROCEDURE, THE PHYSICIAN IDENTIFIED A BROKEN PULLING WIRE. THEY LOST THE ABILITY TO CURVE DURING THE PROCEDURE. THEY REPLACED WITH A LIKE DEVICE AND COMPLETED THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523945 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SF UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, MEDICATION AND BLOOD TRANSFUSION. DURING THE PROCEDURE, WHILE ABLATION WAS PERFORMED TOWARDS THE ANNULUS, A STEAM POP WAS HEARD. THE POWER WAS AT 35WATTS AND SMART ABLATE WAS RUNNING AT 15ML/MIN AS PER RECOMMENDATIONS. AT THE END OF THE PROCEDURE DURING THE CTI LINE ABLATION, CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. 1 UNIT OF BLOOD AND 1 UNIT OF FRESH FROZEN PLASMA (FFP) WERE ADMINISTERED. MEDICATION (INOTROPES) WAS ALSO ADMINISTERED. THE PROCEDURE DELAYED FOR 30 MINUTES. THREE DAYS OF EXTENDED HOSPITALIZATION WERE REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN THOUGHT THE ADVERSE EVENT COULD HAVE BEEN RELATED TO PATIENT¿S ANATOMY OR TO THE BIOSENSE WEBSTER, INC. CATHETER; HOWEVER; HE WASN¿T SURE. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT P

  Patient problems: Cardiac Tamponade

  MAUDE report 8095843 ↗

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