IntellaNav™ ST M004R5031TH0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729963974), received between Jul 13, 2021 and Oct 23, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P920047); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CONCOMITANT PROCEDURE TO TREAT ATRIAL FIBRILLATION USING ABLATION AND TO IMPLANT A LEFT ATRIAL APPENDAGE DEVICE THE PATIENT DEVELOPED CARDIAC TAMPONADE. AN INTELLANAV ST ABLATION CATHETER WAS USED TO PERFORM RADIO FREQUENCY ABLATIONS DURING THE PROCEDURE. APPROXIMATELY TWENTY MINUTES AFTER THE PROCEDURE HAD BEEN COMPLETED TAMPONADE WAS IDENTIFIED WHILE THE PATIENT WAS IN THE RECOVERY ROOM. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS THEN MOVED TO AN OPERATING ROOM FOR SURGERY. A PERFORATION INFERIOR TO THE LEFT INFERIOR PULMONARY VEIN (LIPV) WAS FOUND DURING THE SURGERY. THEY WERE GIVEN BLOOD AND ADMITTED TO THE HOSPITAL FOLLOWING THE SURGERY FOR RECOVERY. THEY WERE SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL AND EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 20516609 ↗
• MalfunctionSep 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A INTELLANAV ST 7/110/2.5/7-4 QUAD STD DURING PREPARATION, WHEN THE PHYSICIAN OPENED THE PACKAGE, THE DEVICE HAD THE FOURTH ELECTRODE ON THE TOP OF THE TUBES DAMAGED. TO SOLVE THE ISSUE THE CATHETER WAS REPLACED, AND PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS ALREADY DISPOSED SO IT WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844066 ↗
• MalfunctionJun 22, 2023Temperature Problem; Temperature Problem

  THE INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER (STABLEPOINT) WAS SELECTED FOR USE DURING THE RADIO FREQUENCY ABLATION PROCEDURE TO TREAT REPEATED SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT THE TEMPERATURE OF THE DEVICE COULD NOT REACH THE SET VALUE, IT WOULD NOT RISE. THE ISSUE WAS PERSISTENT. THE DEVICE WAS EXCHANGED WITH A NEW ONE FROM THE SAME MODEL AND THE PROCEDURE WAS COMPLETED SUCCESFULLY. NO DAMAGE AND NO PATIENT COMPLICATIONS WERE NOTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185684 ↗
• MalfunctionMay 1, 2023Temperature Problem; Temperature Problem

  THE INTELLANAV ST CATHETER WAS SELECTED FOR USE DURING PROCEDURE FOR DUAL ATRIOVENTRICULAR NODAL PATHWAYS TO TREAT TACHYCARDIA. IT WAS REPORTED THAT WHEN APPROACHING THE TISSUE, TEMPERATURE WAS TOO HIGH, DISCHARGE WAS CUT OFF AND THE ABLATION COULD NOT BE PERFORMED AS EXPECTED. A DIFFERENT DEVICE FROM THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16847756 ↗
• MalfunctionApr 11, 2023Output below Specifications; Output below Specifications

  DURING A PROCEDURE, A INTELLANAV ST WAS SELECTED FOR USE. IT WAS REPORTED THAT A DURING ABLATION THE POWER COULD NOT INCREASE TO 5W-10W DESPITE MULTIPLE ATTEMPTS. NO ERROR CODES WERE DISPLAYED. AFTER MANY ATTEMPTS, THE PHYSICIAN REPLACED THE CATHETER. NO PATIENT COMPLICATIONS OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714635 ↗
• MalfunctionJan 27, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 05JAN2023. IT WAS REPORTER THAT DURING PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA IN THE TRICUSPID ANNULUS, AN INTELLANAV ST CATHETER WAS SELECTED FOR USE. DURRING THE PROCEDURE THE CATHETER WAS DEFORMED. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION FOR LABORATORY ANALYSIS. PRODUCT INVESTIGATION REVEALED A BREAK IN THE PROXIMAL PART OF THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253767 ↗
• MalfunctionNov 15, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING AN INTELLANAV ST CATHETER THE POWER COULD NOT BE INCREASED DURING ABLATION. THEY ATTEMPTED TO INCREASE THE POWER BY 5-10W, HOWEVER, THEY COULD NOT INCREASE IT. THEY EXCHANGED THE CATHETER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799523 ↗
• MalfunctionOct 24, 2022Defective Device; Defective Device

  DURING A RADIOFREQUENCY CARDIAC ABLATION A INTELLANAV ST WAS SELECTED FOR USE. THE DEVICE DISCONTINUOUS DISCHARGE AND POOR DISCHARGE. AN EXCHANGE OF THE DEVICE RESOLVED THE PROBLEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. FURTHERMORE, ADDITIONAL INFORMATION CLARIFIED THAT WHEN THE PHYSICIAN STEPPED ON THE PEDAL, IT WAS SUPPOSED TO DISCHARGE CONSTANTLY TO ABLATE, BUT WITH THIS DEVICE, IT WOULD STOPPED AUTOMATICALLY AFTER A SHORT WHILE, AND THE PHYSICIAN HAD TO STEP ON THE PEDAL AGAIN. THE ABLATE COULD NOT BE PERFORMED. THEN THE PHYSICIAN USED ANOTHER OF SAME DEVICE AND THE ISSUE NO LONGER EXIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658191 ↗
• MalfunctionMar 4, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN SUPRAVENTRICULAR VELOCITY(SVT) ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION USING AN INTELLANAV ST CATHETER, THE RF POWER DID NOT INCREASE AND WAS UNABLE TO REACH THE DESIRED TEMPERATURE OUTPUT UPON ATTEMPT TO DELIVER ABLATION ENERGY. THE CATHETER WAS EXCHANGED WITH ANOTHER OF SAME DEVICE. AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13672536 ↗
• MalfunctionJul 13, 2021Contamination; Contamination

  AN INTELLANAV ST WAS SELECTED FOR USE. THE RHYTHMIA MAPPING SPECIALIST OBSERVED BLACK DISCOLORATION INSIDE STERILE PACKAGE THEREFORE THE CATHETER COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P920047. One submission often covers many models, so check the product and lot details in each record.

• Z-0202-2019 · Jun 20, 2018 · Open, Classified
  Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
• Z-0973-2011 · Jul 14, 2009 · Terminated
  RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000
• Z-1617-2008 · Feb 14, 2008 · Terminated
  Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (