ThermoCool SF NAV D131504Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835009255), received between Dec 30, 2016 and Dec 30, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2016Thermal Decomposition of Device

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATYPICAL ATRIAL FLUTTER WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED AN ACUTE MYOCARDIAL INFARCTION (AMI) REQUIRING PACING AND CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND PHARMACOLOGIC SUPPORT. DURING ABLATION, ST ELEVATION WAS NOTED IN THE INFERIOR LEADS (II, III, AND AVF). PATIENT WAS PACED VIA THE ABLATION CATHETER IN THE RIGHT VENTRICULAR APEX. PATIENT WENT INTO CARDIAC ARREST AND CPR WAS INITIATED AND PHARMACOLOGIC SUPPORT WAS PROVIDED. CORONARY ANGIOGRAM REVEALED NO PATHOLOGY. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. IT WAS NOTED THAT THE PATIENT REMAINED IN ATRIAL FLUTTER THROUGHOUT THE PROCEDURE. THE FLUTTER WAS UNALTERED BY THE EVENT OR BY THE ABLATION PROCEDURE AT THAT TIME. IT WAS ALSO NOTED THAT THE PATIENT LATER RETURNED TO SINUS RHYTHM. PATIENT HAS A HISTORY OF PRIOR PULMONARY VEIN ISOLATION (PVI) ABLATION. PHYSICIAN IS UNCERTAIN REGARDING THE CAUSE OF THE ADVERSE EVENT. PHYSICIAN CONFIRMED THAT THE ADVERSE EVENT WAS NOT CAUSED BY BW

  Patient problems: ST Segment Elevation

  MAUDE report 6215545 ↗

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-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-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-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-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