EZ Steer ThermoCool NAV BNI75TCDDHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835003314), received between May 23, 2018 and Apr 16, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. TWO HOURS AFTER THE START OF THE PROCEDURE, A NAVISTAR CATHETER WAS FIRST INSERTED FROM SL0 SHEATH TO MAP THE VT ORIGINATING FROM THE RIGHT VENTRICULAR OUTFLOW TRACK (RVOT). BECAUSE THE PERSISTENCE OF VT WAS POOR, MULTIPOLAR MAPPING WAS PERFORMED AND WAS REPLACED WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE SL0 SHEATH WAS REPLACED WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND PERFORMED RVOT MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. AFTER IDENTIFICATION OF THE EARLIEST ACTIVATION SITE, NAVISTAR CATHETER WAS INSERTED FROM CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL FOR ABLATION. AFTER THE SITE OF THE EARLIEST EXCITATION WAS ABLATED, THE PROCEDURE WAS INTERRUPTED BECAUSE THE PATIENT¿S BLOOD PRESSURE DECREASED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAPHY, SO THE PROCEDURE WAS DISCONTINUED AND PERICARDIOCENTESIS WAS PERFORMED FOR DRAINAGE. THE PHYSICIAN COMMENTED THAT THERE WERE NO ABNOR

  Patient problems: Cardiac Tamponade

  MAUDE report 11676478 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION AT 20-30 WATTS IN THE RVOT AREA, JUST BENEATH THE PULMONARY VALVE, SIGNIFICANT PATIENT MOVEMENT OCCURRED AS THE PATIENT COUGHED. SUBSEQUENTLY, THE PATIENT BECAME BRADYCARDIC, WHILE REMAINING NORMOTENSIVE. BODY SURFACE ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION OF APPROXIMATELY 1 CM. PATIENT THEN BECAME HYPOTENSIVE WITH A SYSTOLIC BLOOD PRESSURE OF APPROXIMATELY 50 MMHG AND THEN SHE BECAME UNCONSCIOUS. FOLLOW-UP ECHOCARDIOGRAPHY REVEALED THAT THE EFFUSION HAD INCREASED TO APPROXIMATELY 5 CM. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. BLOOD PRESSURE RECOVERED AND THE PATIENT REGAINED CONSCIOUSNESS. PROCEDURE WAS COMPLETED. IT WAS NOTED THAT NO PVCS WERE OBSERVED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS IMPROVED. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OP

  Patient problems: Cardiac Tamponade

  MAUDE report 7539314 ↗

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-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-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