EZ Steer ThermoCool BDI75TCFJRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835002898), received between Mar 24, 2016 and Apr 1, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER THERMOCOOL CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEEK HOUSING BROKEN. TEMPERATURE SENSOR ERROR. CHANGED CABLE AND CHANGED CATHETER. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 09-MAR-2026, OBSERVED THE PEEK HOUSING BROKEN. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF PEEK HOUSING BROKEN ON (B)(6) 2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761323 ↗
• MalfunctionNov 7, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  DURING AN ELECTROPHYSIOLOGY PROCEDURE AT THE HOSPITAL PROCOR, THE DOCTOR REQUESTED TO OPEN THE PRODUCT BIDIRECTIONAL IRRIGATED ABLATION CATHETER EZ STEER THERMOCOOL TC CURVE JF 7,5F, REFERENCE BDI75TCFJRT. WHEN OPENING THE INDICATED PRODUCT, WE FOUND THAT IT WAS NOT THE CORRECT ITEM. INSTEAD, WE FIND A PRODUCT SPECIFYING DF CURVE, INSIDE THE PACKAGE, BELONGING TO THE LOT 31081511M. IT IS IMPORTANT TO NOTE THAT THE DF CATHETER IS DESIGNED FOR SMALLER CURVE TECHNIQUES, WHILE THE JF IS USED FOR LARGER CURVE TECHNIQUES, WHICH CAN SIGNIFICANTLY IMPACT PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631649 ↗
• MalfunctionSep 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV NODE ABLATION PROCEDURE WITH A EZ STEER THERMOCOOL AND PACKAGING FOR THE EZ STEER THERMOCOOL CATHETER SHOWED IT WAS AN FJ CURVE BUT THE CATHETER HAD "DF" PRINTED ON THE ACTUAL CATHETER HANDLE. IT WAS REPORTED THAT THE PACKAGING FOR THE EZ STEER THERMOCOOL CATHETER SHOWED IT WAS AN FJ CURVE, BUT AFTER OPENING THE PACKAGING, IT WAS NOTICED THAT THE EZ STEER THERMOCOOL CATHETER HAD "DF" PRINTED ON THE ACTUAL CATHETER HANDLE, AND THE EZ STEER THERMOCOOL CATHETER WAS A DF CURVE, NOT AN FJ CURVE. THE PROCEDURE CONTINUED JUST USING THE EZ STEER THERMOCOOL DF CURVE CATHETER. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208570 ↗
• InjuryJul 30, 2023Signal Artifact/Noise; Device Sensing Problem; Patient Device Interaction Problem; Signal Artifact/Noise; Device Sensing Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. A REPORT WAS BROUGHT TO BWI'S NOTICE: - DATE OF EVENT: (B)(6) 2023 - HOSPITAL NAME: (B)(6) HOSPITAL - BRAND NAME: BWI - PRODUCT NAME: THERMOCOOL F-J CURVE - PRODUCT CODE: 36Q5JM - LOT/BATCH/EXP: 30993121M - THE PRODUCT WAS NOT BEING USED IN A CLINICAL TRIAL. - THE EVENT HAPPENED DURING A PROCEDURE. - THEY WERE NOT IN THE PROCEDURE AT THE TIME OF THE EVENT. - SURGERY WAS PROLONGED DUE TO THE EVENT. IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER ABLATION AND A STANDARD CTI (CAVOTRICUSPID ISHMUS) LINE THAT THERE WAS NOISE SEEN ON THE PROXIMAL ELECTRODES AND IMPEDANCE WAS DEEMED UNRELIABLE DURING ABLATION. THERE WAS A STEAM POP AND UNFORTUNATELY THE PATIENT EXPERIENCED A TAMPONADE, THAT REQUIRED DRAINING AND SURGICAL INTERVENTION. CUSTOMER PROVIDED OPERATOR¿S PROCEDURE NOTES BELOW: ELECTIVE ADMISSION FOR AF/AFL ABLATION ECGS WITH TYPICAL FLUTTER WAS SEEN BEFORE CAME IN AF. LOCAL ANESTHETIC AND SEDATION US GUIDED RFV ACCESS. 1X7 F SHEATH FOR CS (CORONARY SINUS). 1X8 F SHEATH THEN UPGRADED

  Patient problems: Cardiac Tamponade

  MAUDE report 17421830 ↗
• InjuryMar 24, 2016No Display/Image

  DURING A CARDIAC ABLATION, PHYSICIAN WAS UNABLE TO SEE ELECTRICAL ACTIVITY ON EP MED SYSTEM. CABLES WERE REPLACED, STAFF CHECKED ALL THE CONNECTIONS AND EVENTUALLY CHANGED THE ABLATION CATHETER WITH ONLY SLIGHT IMPROVEMENT. ULTIMATELY, THEY HAD TO SWITCH ABLATION GENERATORS.

  Patient problems: No Information

  MAUDE report 5532313 ↗

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-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-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-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