IntellaNav MiFi™ XP M004MR4500K20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729885726), received between Dec 10, 2018 and Apr 13, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (3 reports).

1 other recall cover devices cleared under the same FDA submission (P020025); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE IN THE CAVOTRICUSPID ISTHMUS (CTI), THE INTELLANAV MIFI XP CATHETER WAS PULLED BACK FROM THE INFERIOR VENA CAVA (IVC) AND A STEAM POP WAS FELT. MOVING TO A DIFFERENT LOCATION THE CATHETER DID NOT HAVE A NOTICEABLE CHANGE IN EFFECTIVENESS OR IMPEDANCE. THE CATHETER WAS PLACED IN THE SAME POSITION AS BEFORE, AND ANOTHER STEAM POP WAS FELT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106741 ↗
• MalfunctionSep 30, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT DURING A ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI XP, INTRACARDIAC ELECTROGRAM(EGM) NOISE WAS PRESENT DURING ABLATION THAT BECAME MORE PRONOUNCED OVER TIME. CHANGING THE CATHETER CONNECTION BOX DID NOT RESOLVE THE ISSUE. CHANGING THE CATHETER RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED, NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE DEVICE REVEALED MAGNETIC ELECTRODES 1 AND 3 HAD CHAR RESIDUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556714 ↗
• InjuryOct 19, 2020Thermal Decomposition of Device; Positioning Problem; Thermal Decomposition of Device; Positioning Problem

  IT WAS REPORTED THAT WHILE PERFORMING CAVO-TRICUSPID ISTHMUS (CTI) LINE ABLATION TO TREAT TYPICAL FLUTTER, USING A SHORT SHEATH AND A INTELLANAV MIFI XP CATHETER, THEY HAD TROUBLE FINALIZING BIDIRECTIONAL BLOCK. THEY HAD NO ISSUES SEEING THE SIGNAL THEY WERE TRYING TO TARGET, BUT THEY WERE UNABLE TO GET THE STABILITY NEEDED TO GET ATTENUATION. THE PHYSICIAN DECIDED TO SWITCH TO A RAMP PROTOCOL AND WHEN HE REMOVED CATHETER, CHAR AND A SMALL PIECE OF CARDIAC TISSUE WAS NOTED ON THE TIP. THERE WAS NO CHANGE NOTED IN THE PATIENT'S VITAL SIGNS, NOR COMPLICATIONS. NO IMPEDANCE RISE WAS NOTICED. THE GENERATOR WAS SET TO 60W/70C/300 OHMS/120SEC. THEY WERE RUNNING THE IRRIGATION AT STANDARD DIRECTION FOR USE (DFU) RATES AND THERE WAS NO INTERRUPTION OF FLOW. IT WAS UNKNOWN HOW MANY ABLATIONS HAD BEEN PERFORMED, AND NO TEMPERATURE INCREASE WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A NEW CATHETER WAS INSERTED. THE PATIENT HAD NO COMPLICATIONS UPON TRANSFER OUT OF THE LABORATORY. THE PRODUCT HAS BEEN RETURNED TO BOSTON SCIENTIFIC AND IS PENDING ANALYSIS.

  Patient problems: Tissue Damage

  MAUDE report 10696810 ↗
• MalfunctionFeb 25, 2020Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT TEMPERATURE SPIKES OCCURRED. A INTELLANAV MIFI XP CATHETER WAS USED IN A ABLATION PROCEDURE. DURING ABLATION THE PHYSICIAN WAS UNABLE TO ACHIEVE DESIRED POWER DELIVERY AND THE TEMPERATURE OFTEN SPIKED AND HE POWER WOULD RESET TO 0. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9751383 ↗
• MalfunctionDec 4, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT EPISODES OF CHAR ON THE CATHETER OCCURRED. DURING AN ABLATION PROCEDURE TO TREAT FLUTTER WITH A INTELLANAV MIFI XP CATHETER, THE PHYSICIAN STARTED AT 70 WATTS, 70 DEGREES TEMP AND THEN INCREASED TO 90 WATTS. THEY WERE GETTING 90 WATTS AND TEMPERATURES IN THE 50S WITH NO IMPEDANCE RISE. WHEN THE PHYSICIAN WAS ABLATING, THEY HAD AN EPISODE OF CHAR ON THE CATHETER. THE TIP WAS CLEANED AND THEY WENT BACK DOWN TO 80 WATTS OR SO (LOWER POWERS WERE RECOMMENDED). THE TEMPERATURE SET POINT WAS 70 DEGREES. HOWEVER, THEY WENT BACK TO 90 WATTS BECAUSE THE PHYSICIAN WASN'T GETTING BLOCK. THEY FINALLY GOT BLOCK ON THIS LAST RADIOFREQUENCY (RF) BURN, BUT WHEN HE PULLED THE CATHETER OUT IT HAD CHAR A SECOND TIME. THE PHYSICIAN ATTRIBUTED THE CHAR TO HIGH WATTS BEING USED. A NON-BOSTON SCIENTIFIC STEERABLE SHEATH WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410471 ↗
• MalfunctionDec 10, 2018Adverse Event Without Identified Device or Use Problem; Data Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 06DEC2018. IT WAS REPORTED THAT CATHETER IMAGE ON THE RHYTHMIA MAPPING SCREEN STARTED MOVING AROUND SPORADICALLY AND THEN DISAPPEARED. HOWEVER, ANALYSIS REVEALED BODY FLUID INGRESS VIA RING 3 SEALS AND ELECTRODE COULD HAVE CAUSED INTERMITTENT TRACKING THAT WAS OBSERVED DURING THE PROCEDURE. VISUAL INSPECTION SHOWS DRIED BODY FLUID FOUND UNDER BOTH RING 3 SEALS AND ELECTRODE. DRIED BODY FLUID ALSO FOUND ON THE HANDLE, MAIN BODY TUBING AND DISTAL END. DRIED SALINE FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020025. 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,