Dual Energy Thermocool Smarttouch SF Catheter D134815Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835026917), received between Sep 23, 2026 and Sep 25, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 18, 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.

• InjurySep 25, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an Atrial Fibrillation (AF) ablation procedure with a Dual Energy Thermocool Smarttouch SF (STSF DE) Catheter and the patient experienced arrhythmia (junctional rhythm).During an AF procedure with general anesthesia, they decided to do superior vena cava (SVC) isolation with the STSF DE with Pules Field Ablation (PFA). They did mapping with Pentaray during Coronary Sinus (CS) pacing and then did the ablation. After encircling the SVC, they did a remap to check for isolation and then stopped pacing to check during sinus rhythm. However, when pacing was stopped, the patient did not have any rhythm, so they started pacing again. When pacing slower, a junctional rhythm emerged with a very few sinus beats in between. They then stopped the procedure. After the patient was awake, there was still junctional rhythm and no sinus rhythm. His heart rhythm slowing medications are now stopped and he'll receive a holter examination soon to see whether his sinus rhythm has come back. On (b)(6) 2026: sinus rhythm was restored in patient.The physician's opinion on the cause of the adverse event was that there was temporary stunning of sinus node tissue due to

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 50892949 ↗
• MalfunctionSep 23, 2026Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872757 ↗

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-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-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-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