Celsius RMT ThermoCool CR7TCSIRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835003901), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 injury.

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 18, 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.

• InjuryJun 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH CELSIUS RMT THERMOCOOL AND THE PATIENT EXPERIENCED HYPOTENSION, PRESSURE ON THE HEART, PERICARDIAL EFFUSION, CODED, CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED AND CARDIAC PERFORATION WAS TREATED WITH PERICARDIOCENTESIS AND REPAIR THE PERFORATION BY OPENING THE CHEST. SOMETIME DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE, AND THERE WAS PRESSURE ON THE HEART. A PERICARDIAL EFFUSION WAS CONFIRMED BY THE SC2000 ULTRASOUND MACHINE. A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED. ABOUT 400-450CC OF BODY FLUID WAS REMOVED. THE PATIENT CODED AND CPR WAS PERFORMED. THE PHYSICIAN OPENED THE CHEST TO REPAIR THE PERFORATION. THE PATIENT WAS EXTUBATED, DOING WELL AND MOVING AROUND. THE ABLATION WAS DONE DURING THE CASE BUT THERE WAS "NO IMPEDANCE RISE, AND THE PHYSICIAN DID NOT THINK IT'S A RESULT OF A STEAM POP". THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE INJURY BUT NOTED THAT THE TISSUE OF THE LEFT VENTRICLE WAS ABNORMAL. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. THE INTERVENTION PROVIDED WAS PERICARDIAL SYNTHESIS AND CARDIOTHORAC

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 22154890 ↗

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-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-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-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