IntellaNav MiFi™ XP M004MR45000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729885719), received between Nov 17, 2016 and Dec 18, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Temperature Problem; Temperature Problem

  THE INTELLANAV MIFI CATHETER WAS SELECTED FOR USE DURING THE ABLATION PROCEDURE TO TREAT ATYPICAL FLUTTER. IT WAS REPORTED THAT CATHETER WAS INEFFECTIVE WITH ABLATION. THERE WAS NO TEMPERATURE INCREASE. THE ABLATE FROM CATHETER HAD NO EFFECT ON 20 ABLATION POINTS. THE CATHETER WAS REMOVED FROM THE BODY AND REPLACED WITH A NEW ONE FROM THE SAME MODEL. ABLATION WAS PERFORMED ON THE SAME POSITION AND WAS EFFECTIVE. THE PROCEDURE WAS COMPLETED SUCCESFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345104 ↗
• MalfunctionDec 11, 2018No Device Output; No Device Output

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 06-DEC-2018. IT WAS REPORTED THAT THE MAGNETIC SENSOR FAILED. DURING AN ATYPICAL FLUTTER ABLATION PROCEDURE WITH AN INTELLANAV MIFI XP CATHETER WAS USED. IT WAS REPORTED THAT TOWARDS THE END OF THE CASE, THEY WERE GETTING READY TO FINISH UP, GOT A FEW MORE ABLATIONS TO DELIVER AND THE MAGNETIC SENSOR IN THE CATHETER BROKE. THEY WERE ABLE TO TRACK IT THROUGH IMPEDANCE TRACKING WITHOUT USING THE MAGNETIC SENSOR. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, ANALYSIS REVEALED FLUID INGRESS INTO DISTAL END CAVITY VIA RING 3 SEALS. VISUAL INSPECTION SHOWS DRIED BODY FLUID UNDER BOTH RING 3 SEALS AND ELECTRODE. DRIED BODY FLUID FOUND ON THE HANDLE, MAIN BODY TUBING AND DISTAL END. ELECTRICAL CONTINUITY CHECKS REVEALED NO ELECTRICAL SHORTS, AS CHECKED MANUALLY USING A MULTI-METER AND BREAKOUT BOX. THE MAG SENSOR MEASURED ELECTRICALLY OPEN IN STRAIGHT, RIGHT AND LEFT CURVE CONFIGURATIONS. ALL ELECTRODES AND THERMISTOR RESISTANCES MEASURED IN SPEC AND WERE TYPICAL. THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. X-RAY FOUND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151890 ↗
• MalfunctionNov 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THERE WAS FOREIGN MATERIAL ON THE CATHETER. AN INTELLANAV¿ MIFI XP ABLATION CATHETER WAS REMOVED FROM THE PACKAGING PRIOR TO AN ABLATION PROCEDURE. WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING, THERE APPEARED TO BE A PIECE OF STICKY GLUE ON THE CATHETER ITSELF. THE GLUE WOULD NOT HAVE ALLOWED THE CATHETER TO SLIDE THROUGH THE VENOUS SHEATH. THE DEVICE WAS NOT USED WITHIN THE PATIENT; ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 7047976 ↗
• MalfunctionOct 19, 2017Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT HIGH IMPEDANCE OCCURRED. THE PHYSICIAN WAS UNABLE TO ABLATE DUE TO A HIGH IMPEDANCE WARNING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME CATHETER WITH NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS FOUND FOREIGN MATTER AND BODY FLUID UNDER THE SEAL OF RING 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962413 ↗
• InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) STUDY. IT WAS REPORTED THAT 30 MIN POST ABLATION WITH AN INTELLANAV¿ MIFI XP CATHETER, THE PATIENT ABRUPTLY DEVELOPED HYPOTENSION. LIMITED ECHO CONFIRMED PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED. THE EVENT WAS CONSIDERED RESOLVED ON THE SAME DATE.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 6110841 ↗

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,