ThermoCool SF D131604Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835009347), received between Oct 9, 2018 and Oct 9, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF UNI-DIRECTIONAL CATHETER AND STOCKERT AND DEVELOPED A CEREBROVASCULAR ACCIDENT AND ESOPHAGEAL FISTULA (REQUIRING SURGICAL INTERVENTION). POST-PROCEDURE, THE PATIENT WAS ADMITTED INTO EMERGENCY ROOM (ER) WITH SYMPTOMS FROM THE ABLATION PROCEDURE. THE PATIENT HAD TRANSIENT ISCHEMIC ATTACKS (TIAS), CHEST PAIN AND DYSPHAGIA EVERY TIME HE ATE AS WELL AS RASH ON HIS CHEST. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT. ESOPHAGEAL FISTULA WAS CONFIRMED BY CT SCAN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM (OR) TO HAVE SURGERY. A STENT IN THE ESOPHAGUS AND A PATCH OVER THE LEFT ATRIUM WHERE THE FISTULA OCCURRED WERE REQUIRED. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO BE IN CRITICAL CONDITION. EXTENDED HOSPITALIZATION WAS REQUIRED POST-SURGERY TO MONITOR PATIENT¿S CONDITION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, BURNING THE TISSUE OF THE POSTERIOR WALL OF THE LEFT ATRIUM CAUSED THE INJURY. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY

  Patient problems: Fistula; No Code Available; Stroke/CVA

  MAUDE report 7947518 ↗

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-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-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-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