ThermoCool SF NAV D131501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835009231), received between Feb 21, 2017 and Nov 27, 2023 — classified as 2 injuries.

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

• InjuryNov 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ARTICLE WAS RECEIVED ENTITLED "50W VS 40W DURING HIGH-POWER SHORT-DURATION ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION" THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: COSTEA A, DIAZ JC, OSORIO J, MATOS CD, HOYOS C, GOYAL S, TE C, D'SOUZA B, RASTOGI M, LOPEZ-CABANILLAS N, IBANEZ LC, THORNE C, VARLEY AL, ZEI PC, SAUER WH, ROMERO JE. 50W VS 40W DURING HIGH-POWER SHORT-DURATION ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: A MULTICENTER PROSPECTIVE STUDY. JACC CLIN ELECTROPHYSIOL. 2023 SEP 5:S2405-500X(23)00618-7. DOI: 10.1016/J.JACEP.2023.08.005. EPUB AHEAD OF PRINT. PMID: 37804258. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND HIGH-POWER SHORT-DURATION (HPSD) RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION (AF) INCREASES FIRST-PASS PULMONARY VEIN ISOLATION (PVI) AND FREEDOM FROM ATRIAL ARRHYTHMIAS WHILE DECREASING PROCEDURAL TIME. HOWEVER, THE OPTIMAL POWER SETTING IN TERMS OF SAFETY AND EFFICACY HAS NOT BEEN DETERMINED. OBJECTIVES THIS STUDY COMPARED THE PROCEDURAL CHARACTERISTICS AND CLINICAL OUTCOMES OF 50W VS 40W DURING HPSD ABLATION OF PAROXYSMAL AF. METHODS PATIENTS FROM THE REAL-AF PROSPECTIVE MULTICENTER REGISTRY (REAL-WORLD EXPERIENC

  Patient problems: Heart Failure/Congestive Heart Failure; Pericardial Effusion; Pericarditis

  MAUDE report 18211843 ↗
• InjuryFeb 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A BIPOLAR ABLATION PROCEDURE (WITH 2 CATHETERS) FOR VENTRICULAR TACHYCARDIA WITH A THERMOCOOL SF NAV CATHETER AND A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. TWO HOURS POST-PROCEDURE, A TAMPONADE WAS DETECTED. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. PATIENT FULLY RECOVERED. 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 PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNSPECIFIED NEEDLE AND A ST. JUDE MEDICAL-ABBOTT SL0 SHEATH. SHEATH IN USE WAS A ST. JUDE MEDICAL-ABBOTT AGILIS L CURVE. GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH POWER UP TO 30 WATTS (NOT TITRATED) AND IMPEDANCE UP TO 150-160 OHMS. OVERALL ABLATION TIME WAS 7.5 MINUTES. LAST ABLATION CYCLE TIME WAS 10 SECONDS. IRRIGATED CATHETER FLOW WAS SET AT 15 ML/MIN FOR BOTH CATHETERS. PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAI

  Patient problems: Cardiac Tamponade

  MAUDE report 6347540 ↗

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-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-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-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-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