NaviStar ThermoCool NI75TCBHRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10846835008333), received between Jun 13, 2018 and Mar 11, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON INTRACARDIAC (IC) CHANNELS ON BOTH THE CARTO3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN DID HAVE OTHER INTACT ECG SIGNALS AVAILABLE TO MONITOR PATIENT HEART RHYTHM. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED NOISE ON IC SIGNALS IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 18-FEB-2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574434 ↗
• InjuryMar 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND PATIENT EXPERIENCED PULMONARY VEIN STENOSIS. AFTER ABLATION, PULMONARY VEIN STENOSIS OCCURRED AND EXPLANATION TO THE PATIENT HAS BEEN REQUESTED. THE PATIENT UNDERWENT ABLATION (ABL) IN 2011, SO IT IS UNKNOWN WHICH PRODUCTS WERE USED. IT IS NOT POSSIBLE TO CONFIRM HOW LONG AFTER ABL THE EVENT OCCURRED. THE PATIENT WAS CONDUCTED ABLATION IN 2011, WHICH RESULTED IN PULMONARY VEIN STENOSIS. THE EVENT WAS REVEALED WHEN THE CARTO3 IMAGE WAS REQUESTED FROM THE PHYSICIAN TO EXPLAIN TO THE PATIENT. THERE HAVE BEEN NO REPORTS RECEIVED THAT THIS WAS CAUSED BY A DEFECT IN THE BIOSENSE WEBSTER, INC. PRODUCTS.

  Patient problems: Stenosis

  MAUDE report 18956768 ↗
• MalfunctionJul 13, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A DEFLECTION STUCK ISSUE OCCURRED. INITIALLY IT WAS REPORTED THAT THERE WAS A DEFLECTION ISSUE. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE DEFLECTION ISSUE REPORTED WAS ASSESSED AS NON MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. ADDITIONAL INFORMATION WAS RECEIVED ON 19-JUN-2023. IT WAS STUCK IN A FULL DEFLECTED POSITION. THE KNOB/PISTON WAS ABLE TO BE TURNED. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE CATHETER WAS STUCK IN A FULL DEFLECTED POSITION ON (B)(6) 2023 AND HAVE REASSESSED THE EVENT AS REPORTABLE FOR A DEFLECTION STUCK ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321285 ↗
• MalfunctionApr 6, 2023Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A NAVISTAR THERMOCOOL: HOWEVER, THE DEVICE WAS DAMAGED WITHIN THE PACKAGING. THE DEVICE WAS FOUND TO HAVE BEEN CRACKED WHEN THE PACKAGE WAS OPENED (WITH SOME WIRES EXPOSED). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE DEVICE WASN¿T USED ON THE PATIENT. OUT OF BOX FAILURE IS NOT MDR-REPORTABLE. BROKEN TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691500 ↗
• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP ISSUE OCCURRED. DEVICE DAMAGED. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS DAMAGED. PHOTO PROVIDED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A BROKEN TIP ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16605030 ↗
• MalfunctionJan 25, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB INSPECTED THE DEVICE AND THE PEEK HOUSING WAS FOUND CRACKED WITH EXPOSED WIRES. INITIALLY, IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 28-DEC-2022 THAT THE PEEK HOUSING WAS FOUND CRACKED WITH EXPOSED WIRES. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 28-DEC-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238616 ↗
• MalfunctionMar 18, 2022Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE DEFLECTION MECHANISM WAS STUCK IN A DEFLECTED POSITION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION AND THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER¿S INITIAL REPORTED DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE SINCE INSUFFICIENT DEFLECTION OR NOT RELAXING COMPLETELY (WITHOUT BEING STUCK IN THE DEFLECTED POSITION) HAS A MOST LIKELY CONSEQUENCE OF AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON 17-FEB-2022, BWI¿S PAL REVEALED THE VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE DEFLECTION TEST FAILED. THE DEVICE WAS ONLY DEFLECTING BUT NOT RELAXING. THE ISSUE OF DEFLECTION BEING STUCK IS CONSIDERED TO BE AN MDR REPORTABLE MALFUNCTION. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13811512 ↗
• MalfunctionMar 2, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A DEFLECTION STUCK ISSUE OCCURRED. INITIALLY IT WAS REPORTED THAT THERE WAS A DEFLECTION ISSUE. DURING THE PROCEDURE, THE NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE EVENT WAS ASSESSED AS NOT MDR REPORTABLE FOR A DEFLECTION ISSUE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. ADDITIONAL INFORMATION WAS RECEIVED ON 07-FEB-2022. THE CURVE OF THE CATHETER WAS STUCK JAMMED IN A FULL DEFLECTED POSITION. THE KNOB/PISTON WAS ABLE TO BE TURNED AND PUSHED UP AND DOWN. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER. THE ADDITIONAL INFORMATION STATING THAT THE CATHETER WAS STUCK JAMMED IN A FULL DEFLECTED POSITION WAS ASSESSED AS AN MDR REPORTABLE DEFLECTION STUCK ISSUE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE ISSUE IS 07-FEB-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657399 ↗
• MalfunctionNov 2, 2021Crack; Positioning Problem; Crack; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB FOUND THE PEEK HOUSING CRACKED WITH INTERNAL PARTS EXPOSED. INITIALLY, IT WAS REPORTED THAT DURING THE SVT OPERATION, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY . THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON (B)(6) 2021 THAT THE PEEK HOUSING WAS CRACKED WITH INTERNAL PARTS EXPOSED. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738260 ↗
• MalfunctionOct 19, 2020Signal Artifact/Noise; No Display/Image; Signal Artifact/Noise; No Display/Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THERE WAS NO SIGNAL AVAILABLE FOR THE PHYSICIAN TO MONITOR THE PATIENT¿S HEART RHYTHM. INITIALLY IT WAS REPORTED THAT THERE WAS BAD/PARTIAL SIGNAL INTERFERENCE (NOISE/LOSS) OBSERVED ON BOTH INTRACARDIAC AND BODY SURFACE CHANNELS. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, WITH THE INFORMATION AVAILABLE, THIS SIGNAL ISSUE WAS ASSESSED AS NOT MDR REPORTABLE AS THE RISK TO THE PATIENT WAS LOW FOR PARTIAL SIGNAL INTERFERENCE (NOISE/LOSS). ADDITIONAL INFORMATION WAS RECEIVED ON 9/22/2020 AS IT WAS CLARIFIED THAT THE SIGNAL INTERFERENCE (NOISE/LOSS) WAS OBSERVED ON INTRACARDIAC CHANNELS. THE SIGNAL INTERFERENCE WAS SEEN ON THE CARTO 3 SYSTEM ONLY SINCE NO OTHER EQUIPMENT WAS USED TO MONITOR THE PATIENT¿S HEART RHYTHM. THERE WAS NO SIGNAL AVAILABLE FOR THE PHYSICIAN TO MONITOR THE PATIENT¿S HEART RHYTHM. DURING THE INTERFERENCE, THE CATHETER WAS INSIDE THE PATIENT¿S BODY. SINCE IT WAS CLARIFIED THAT THERE WAS NO SIGNAL AVAIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10702685 ↗
• MalfunctionJun 13, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER. DURING THE PROCEDURE, THE PHYSICIAN FOUND THE INNER PACKAGE WAS DAMAGED. HE EXCHANGED THE CATHETER TO COMPLETE THE PROCEDURE. ADDITIONAL CLARIFICATION WAS RECEIVED ON THE EVENT ON JANUARY 1, 2018 WHICH CONFIRMED THAT THE PRODUCT WAS NEVER USED ON THE PATIENT. THE PICTURES ATTACHED REFLECTS THAT THE DEVICE PACKAGING (POUCH) WAS WORN AND RAGGED; HOWEVER, THERE WAS NO INDICATION THAT THE STERILITY OF THE DEVICE COULD BE COMPROMISED DUE TO THIS ISSUE. THIS INITIAL INNER PACKAGE (POUCH) ISSUE WAS ASSESSED AS NOT REPORTABLE. IF THE PACKAGING OF THE DEVICE WAS WORN, BENT, RAGGED, CONTAINED A CUT OR SLIT, OR APPEAR RIPPED; HOWEVER, THERE WAS NO DAMAGE TO THE POUCH NOR OTHER STERILITY COMPROMISES, THEN THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY WAS REMOTE. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 14, 2018 WHICH CLARIFIED THAT THE DAMAGE OBSERVED ON THE INNER PACKAGE REPRESENTED A RISK TO THE STERILITY OF THE DEVICE. THEREFORE, SINCE THERE WAS A RISK TO THE STERILITY OF THE DEVICE, THIS ISSUE HAS NOW BEEN REASSESSED AS A REPORTABLE MALFUNCTI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7595014 ↗

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-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-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-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