Celsius ThermoCool DI7TCFLRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835000450), received between Jan 16, 2019 and Feb 10, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Insufficient Cooling; Patient Device Interaction Problem; Insufficient Cooling; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ATRIAL FLUTTER ABLATION PROCEDURE WITH A CELSIUS¿ THERMOCOOL¿ UNI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PROLONGED HOSPITALIZATION. THIS WAS FOR TREATMENT OF ATRIAL FLUTTER IN THE RIGHT ATRIUM. CELSIUS¿ THERMOCOOL¿ UNI-DIRECTIONAL CATHETER WAS USED IN COMBINATION WITH A SMARTABLATE GENERATOR. THE ABLATION WAS PERFORMED AT 50WATT. THIS WAS AN ABLATION PROCEDURE USING THE FLUOROSCOPY SYSTEM ONLY, WITHOUT THE USE OF THE CARTO SYSTEM FOR MAPPING. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TEMPERATURE INDICATOR LIGHT OF THE GENERATOR FLASHED SEVERAL TIMES, INDICATING THAT THE TEMPERATURE AT THE TIP OF THE CATHETER ROSE ABOVE 43ºC AND ONCE DURING THE PROCEDURE, THE TEMPERATURE INDICATOR LIGHT LIT CONTINUOUSLY, AND THE GENERATOR'S PROTECTIVE MECHANISM WAS ACTIVATED, CUTTING OFF THE OPERATION OF THE GENERATOR WHEN THE TEMPERATURE ROSE ABOVE 50ºC. AFTER THE GENERATOR CUTOFF AND AFTER THE ELECTROPHYSIOLOGIST INDICATED THAT HE DID NOT FEEL HE WAS PRESSING TOO HARD ON THE TISSUE, THE MEDICAL TEAM DECIDED TO INCREASE THE IRRIGATION TO 45ML/MIN. DESPITE THE INCREASED IRRIGATION, THE TEMPERATURE IND

  Patient problems: Cardiac Perforation

  MAUDE report 21345124 ↗
• MalfunctionOct 14, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THERE WAS AN IRRIGATION ISSUE NOTED. AN AV (ATRIOVENTRICULAR) NODE ABLATION WAS PERFORMED AND THERE WAS A HIGH TEMPERATURE INDICATED ON THE GENERATOR. AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN TOOK THE CATHETER OUT OF THE BODY, THE DOCTOR LOOKED AT THE IRRIGATION AND REALIZED ONE PORT DIDN'T SEEM NORMAL. THERE WERE NO ISSUES WITH THE PROCEDURE OR THE GENERATOR. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444598 ↗
• MalfunctionJun 19, 2024Insufficient Cooling; Off-Label Use; Device Contamination with Body Fluid; Obstruction of Flow; Insufficient Cooling; Off-Label Use; Device Contamination with Body Fluid; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR (AV) NODE CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THEY KEPT HAVING ¿TEMP RAISES¿ (HIGH TEMPERATURE) ON THE TIP OF THE CATHETER. THE PATIENT HAD A VERY THICK HEART TISSUE, SO THE PHYSICIAN OPTED ON HIS OWN ACCORD TO GO OFF-LABEL AND ABLATE AS A NON-IRRIGATED CATHETER, WITH THE THERMO COOL. THE PHYSICIAN WAS INFORMED THAT THIS WAS OFF-LABEL. LATER, DURING THE CASE, THEY FELT LIKE THE ENERGY WAS TOUCHING THE TISSUE, SO THE CATHETER WAS PULLED AND FOUND THAT THE TIP OF THE CATHETER HAD TWO OF THE IRRIGATION HOLES THAT WERE CLOGGED AND NOT IRRIGATING, AND THERE WAS CHAR ON THE TIP OF THE CATHETER. THE PHYSICIAN OPTED NOT TO PUT THE CATHETER BACK IN THE BODY, BUT TO OPEN A NEW ONE. A QUESTION WAS ASKED ON WHETHER THE ¿HOLDS CLOGGED¿ BEFORE OR AFTER THE OFF-LABEL USE. THE PHYSICIAN WANTED TO SEND THE CATHETER IN FOR EVALUATION. THE CASE CONTINUED. NO REPLACEMENT WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT CONSIDER THE CHAR TO BE EXCESSIVE (BASED ON THEIR CLINICAL EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571329 ↗
• MalfunctionApr 10, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND AN IRRIGATION ISSUE DURING USE ON PATIENT OCCURRED. THE CATHETER HAS AN IRRIGATION DEFECT AT THE TIP WHICH CAUSES AN INCREASE IN TEMPERATURE DURING ABLATION. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE NGEN PUMP WAS USED. THE HIGH TEMPERATURE ERROR WAS NOTED FROM THE IRRIGATION PUMP. THEY REPLACED THE CATHETER TO RESOLVE THE IRRIGATION ISSUE. CORRECT CATHETER SETTINGS WERE SELECTED ON THE NGEN GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. THE TEMPERATURE CUT-OFF VALUE WAS EXCEEDED BY A FEW SECONDS. THEY DO NOT NEED SERVICING ON THE EQUIPMENT. THEY ARE USING THE NGEN PUMP AND NGEN GENERATOR WITHOUT PROBLEMS NOW. THE HIGH TEMPERATURE ERROR WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE IRRIGATION ISSUE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085549 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN APPROXIMATELY (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING EPICARDIAL PUNCTURE. INITIALLY, IT WAS REPORTED THAT THE CATHETER PRESENTED IMPEDANCE VARIATION. THERE WAS NO SIGNIFICANT DELAYS TO THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON (B)(6) 2018. DURING THE ABLATION PHASE, CARDIAC TAMPONADE WAS CONFIRMED. EPICARDIAL PUNCTURE WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID. THE PATIENT REQUIRED AN EXTRA DAY OF HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. THERE WERE NO FACTORS CITED THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE IMPEDANCE DISPLAYED WAS 150 OHMS. THE SYSTEM STOPPED THE ABLATION WHEN THE CUT-OFF VALUE WAS EXCEEDED. THE STOCKERT GENERATOR WAS USED AT 30 WATTS WITH A TEMPERATURE CUT-OFF VALUE AT 43 DEGREES CELSIUS AND A POWER CUT-OFF AT 180 WATTS. THE PARAMETERS OBSERVED DURING THE PROCEDURE INCLUDED POWER OF 30 WATTS, TEMPERAT

  Patient problems: Cardiac Tamponade

  MAUDE report 8255000 ↗

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-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-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