EZ Steer ThermoCool BDI75TCDFRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835002874), received between Aug 8, 2018 and Jul 2, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Cooling” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH AN EZ STEER THERMOCOOL AND 3 IRRIGATION HOLES WERE NOT IRRIGATING. IT WAS REPORTED THAT THE NONNAV CATHETER KEPT HAVING TEMPERATURE RISES ON NGEN GENERATOR REMOTE MONITOR. THE CALLER STATED THEY WERE NOT PRESENT DURING THE PROCEDURE. THE CALLER STATED THE CATHETER WAS REMOVED FROM THE BODY TO FLUSH. THE CALLER STATED THEY NOTICED 3 IRRIGATION HOLES WERE NOT IRRIGATING. THE CORRECT CATHETER SETTING WERE SELECTED ON THE GENERATOR AND THERE WERE NO FLOW RATE THE CALLER STATED THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391659 ↗
• InjuryOct 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED A MILD THROMBOEMBOLIC EVENT. CUSTOMER INFORMED US THREE DAYS AFTER THE PROCEDURE THAT THE PATIENT HAD A MILD THROMBOEMBOLIC EVENT AFTER AN INTENSIVE VT ABLATION IN THE LEFT VENTRICLE. THEY DON¿T THINK IT IS RELATED TO THE PRODUCT BUT MORE TO THE PATIENT CONDITION. IN THE MEANTIME THE PATIENT IS FINE AGAIN AND THERE ARE NO FURTHER CONSEQUENCES. THERE WAS NO POST-OP DEVICE MALFUNCTION. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PATIENT CONDITION. IT IS UNKNOWN IF INTERVENTION WAS REQUIRED. PATIENT OUTCOME WAS REPORTED AS FULLY RECOVERED. PROLONGED HOSPITALIZATION IS UNKNOWN. SINCE THE EVENT IS LIFE THREATENING AND REQUIRED CANCELLATION OF THE PROCEDURE TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 12613431 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND A THROMBOSIS. DURING THE ABLATION PHASE, WHILE ABLATING THE CAVOTRICUSPID ISTHMUS (CTI), A STEAM POP OCCURRED. THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED AND 1 LITER OF FLOOD WAS DRAINED FROM THE PERICARDIUM. THE PATIENT RECEIVED ANTICOAGULANT (PROTAMINE) AND HE HAD A THROMBUS. THE ACTIVATED CLOTTING TIME (ACT) IS UNKNOWN. THERE¿S NO INFORMATION REGARDING MEDICAL/SURGICAL INTERVENTION WHEN THE THROMBUS WAS NOTED. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN¿S CAUSALITY OPINION IS UNKNOWN. IT IS UNKNOWN IF A TRANSSEPTAL PUNCTURE WAS PERFORMED. AN UNKNOWN 8FR 10 CM (LOT:WE04) INTRODUCER AND AN UNKNOWN 6FR, 10CM (LOT: 171010A) INTRODUCER WERE USED DURING THE PROCEDURE. THE GENERATOR PARAMETERS AT THE SITE OF INJURY ARE UNKNOWN. THERE¿S NO INFORMATION REGARDING OVERALL ABLATION AND LAST ABLATION CYC

  Patient problems: Cardiac Tamponade; Thrombosis

  MAUDE report 7760748 ↗

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