ThermoCool SF NAV D131502Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835009248), received between Dec 30, 2016 and Nov 21, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.

• MalfunctionNov 21, 2018Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER. INITIALLY, IT WAS REPORTED THAT THERE WAS NOISE ON ALL ELECTROCARDIOGRAMS WHEN THE THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. SINCE THERE WAS NO EVIDENCE THERE WERE NO INTERPRETABLE SIGNALS ON ALL BODY SURFACE AND INTRACARDIAC SIGNALS ON ALL SYSTEMS, THIS EVENT WAS ASSESSED AS NOT REPORTABLE. THE RISK TO THE PATIENT WAS LOW. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. IT WAS CLARIFIED THAT NO SIGNALS WERE AVAILABLE UNTIL THE CATHETER WAS CHANGED. THE ISSUE WAS OBSERVED ON ALL INTRACARDIAC AND BODY SURFACE SIGNALS ON THE CARTO SYSTEM AND RECORDING SYSTEM. IN ADDITION, NO SIGNALS WERE AVAILABLE ON THE DEFIBRILLATOR AND ANESTHESIA MONITOR. PER THE ADDITIONAL INFORMATION DESCRIBING THAT NO SIGNALS WERE AVAILABLE ON ANY SYSTEM UNTIL THE CATHETER WAS CHANGED, THIS EVENT WAS RE-ASSESSED TO NOT REPORTABLE. THE AWARENESS DATE IS (B)(4) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096771 ↗
• MalfunctionJul 24, 2018No Display/Image; No Display/Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND A LOSS OF ALL ECG SIGNALS ON ALL CHANNELS ISSUE OCCURRED. THERE WERE NO PATIENT CONSEQUENCES. UPON CONNECTION OF THE ABLATION CATHETER, SIGNAL INTERFERENCE OCCURRED ON ALL ECG SIGNALS ON THE CARTO AND THE RECORDING SYSTEM. PHYSICIAN DID NOT HAVE ANY ECG SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. CABLE WAS REPLACED WITHOUT RESOLUTION. THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER WAS REPLACED AND THE ISSUE RESOLVED. PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT OR PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714363 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem

  THIS PI IS PART OF (B)(6) CLINICAL STUDY "BIPOLAR ABLATION FOR ENDOCARDIAL AND EPICARDIAL SIMULTANEOUS ABLATION OF VT¿: IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER AND THERMOCOOL SF NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PERICARDIAL DRAIN. DURING THE STUDY, MID-PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA FLUOROSCOPY. PROTAMINE WAS ADMINISTERED FOR ANTICOAGULANT REVERSAL. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. PERICARDIAL DRAIN WAS LEFT IN PLACE. PATIENT REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION AND NOT TO ANY BIOSENSE WEBSTER, INC. PRODUCT. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNSPECIFIED NEEDLE. THERE IS NO SHEATH INFORMATION. GENERATOR WAS REPORTED TO BE SET TO DEFAULT PAR

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6262487 ↗
• MalfunctionDec 30, 2016Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL SF NAV CATHETER WHERE METAL WAS EXPOSED BETWEEN THE SECOND AND THIRD ELECTRODES. PRIOR TO INSERTION OF THE CATHETER, THE PHYSICIAN SAW A COPPER-LOOKING COLOR IN BETWEEN THE TWO ELECTRODES, AND NOTED THAT IT APPEARED THAT THE INTERNAL WIRING WAS EXPOSED. THE PHYSICIAN CHOSE NOT TO USE THE CATHETER, AND REPLACED IT WITH ANOTHER. THE CASE CONTINUED WITHOUT ANY REPORT OF PATIENT CONSEQUENCE. EXPOSURE TO THE INTERNAL COMPONENTS OF THE CATHETER PRESENTS A CRITICAL RISK OF THROMBUS TO THE PATIENT. AS A RESULT, THIS EVENT IS MDR REPORTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6216562 ↗

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-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-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-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-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