IntellaNav™ ST M004R5031THK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729963950), received between Jan 12, 2021 and Dec 13, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE IS SUSPECTED TO HAVE TEMPERATURE ISSUES. DURING SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AN INTELLANAV ST ABLATION CATHETER WAS SELECTED FOR USE. THE POWER COULD NOT GO UP, AND THE TEMPERATURE COULD ONLY REACH 30. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE HAS BEEN REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925822 ↗
• MalfunctionDec 12, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE PRESENTED POOR TEMPERATURE CONTROL. DURING PROCEDURE, AN INTELLANAV ST ABLATION CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE POWER COULD NOT GO UP, AND THE TEMPERATURE COULD ONLY REACH 30C. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920744 ↗
• InjuryApr 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DURING AN ABLATION PROCEDURE TO TREAT AN AV NODE REENTRY TACHYCARDIA (AVNRT) IN THE ACCESSORY PATHWAY, AN INTELLANAV ST ABLATION CATHETER WAS SELECTED FOR USE. WHILE MAPPING IN THE LEFT ATRIUM WITH THE INTELLANAVST CATHETER, THE PATIENT EXPERIENCED CHEST DISCOMFORT AND DIFFICULTY BREATHING. THE PHYSICIAN CHECKED THE X-RAY AND SAW THAT THE CARDIAC SILHOUETTE WAS NOT MOVING AS IT SHOULD. THE ECHO, OPERATING ROOM (OR) AND ANESTHESIA TEAMS WERE CALLED INTO THE PROCEDURE LABORATORY. IT WAS CONFIRMED THAT THERE WAS A MODERATE EFFUSION. PERICARDIOCENTESIS PROCEDURE DREW OFF APPROXIMATELY 500CC OF BLOOD. THE PATIENT WAS STABLE, BUT THE PROCEDURE WAS ABORTED. ALSO, IT WAS NOTED THAT THE ABLATION CATHETER DID NOT SEEM TO BEHAVE AS NORMAL. THE CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: Chest Pain; Dyspnea; Pericardial Effusion

  MAUDE report 19164698 ↗
• MalfunctionMay 12, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION TO TREAT ATRIAL TACHYCARDIA AN INTELLANAV ST HAD POOR TEMPERATURE CONTROL. WHILE ATTEMPTING TO BURN IN THE CORONARY SINUS, AFTER NOTICING POWER DELIVERY OF 1 W THE TEMPERATURE LIMIT WAS INCREASED FROM 40 TO 45 DEGREES. POWER DELIVERY GOT UP TO 6 W AND THE CATHETER WAS MOVED TO A NEW LOCATION BUT TEMPERATURE READING WAS STILL 38 DEGREES AND THIS POWER WAS MINIMALLY DELIVERED. WHEN MOVING TO THE MIDDLE OF THE RIGHT ATRIUM, TEMPERATURE STILL DIDN'T CHANGE AND THERE WAS NO FLUCTUATION WHILE MOVING IT. THE CATHETER WAS REPLACED TO SOLVE THE ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14381059 ↗
• MalfunctionJan 12, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH AN INTELLANAV ST, THEY EXPERIENCED UNUSUALLY HIGH TEMPERATURE READINGS WITH VERY LOW POWER SETTINGS DURING EVERY ABLATION. THE POWER WAS STARTED AT 5-10 WATTS AND TITRATED UP TO 30 WATTS. TEMPERATURE CONTROL MODE WAS IN USE. NO ERROR MESSAGES OCCURRED. THEY REPLACED THE CATHETER WITH ANOTHER OF THE SAME DEVICE, WHICH WORKED APPROPRIATELY, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OCCURRED AND THE "PATIENT'S OUTCOME WAS FAVORABLE." THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11156730 ↗

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 (