IntellaNav MiFi™ XP M004MR4500N40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729885733), received between Aug 20, 2019 and Mar 31, 2021 — classified as 1 injury, 2 malfunctions.

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

• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT FOLLOWING A CRYOABLATION PROCEDURE WITH A POLARX BALLOON CATHETER, AN INTELLANAV MIFI XP CATHETER AND A POLARSHEATH, THE PATIENT EXPERIENCED PRECORDIAL PLEURITIC CHEST PAIN (CP), DYSPHAGIA, ODYNOPHAGIA. THE PATIENT BEGAN EXPERIENCING CHEST PAIN, PAINFUL/DIFFICULT SWALLOWING AFTER ABLATION PROCEDURE. HE NOTIFIED HIS CARDIOLOGIST WHO DIAGNOSED AND PRESCRIBED MEDICATION. THE PHYSICIAN ORDERED COMPUTED TOMOGRAPHY (CT) AND WAS PRESCRIBED A 15 DAY COURSE OF COLCHICINE 0.6 MG TABLET TWICE DAILY AND PROTONIX 40 MG TWICE DAILY FOR ONE MONTH. THEY REFERRED THE PATIENT TO GASTROENTEROLOGY (GI) FOR FURTHER EVALUATION. A COMPUTED TOMOGRAPHY (CT) REPORT SHOWED NO INTRALUMINAL AIR AROUND THE ESOPHAGUS AND NO INFLAMMATION. THE PHYSICIAN NOTED THAT BASED ON THE PATIENT'S SYMPTOMS, THEY OBTAINED A CT ANGIOGRAM OF THE LEFT ATRIUM TO RULE OUT ATRIAL ESOPHAGEAL FISTULA OR MEDIASTINITIS. THE IMAGES WERE REVIEWED WITH A RADIOLOGIST IN DETAIL. THERE WERE NO SIGNIFICANT ABNORMALITIES ON THE CT SUGGESTIVE OF ANY OF THE ADVERSE EVENTS. THERE WAS A SMALL PLEURAL EFFUSION, OTHERWISE THE STUDY WAS UNCHANGED FROM THE PREOPERATIVE STUDY. THE PATIENT WAS GENERALLY FEELING WELL. THE PAT

  Patient problems: Chest Pain; Dysphagia/ Odynophagia; Pain

  MAUDE report 11596280 ↗
• MalfunctionJan 21, 2020Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON DECEMBER 23 2019. IT WAS REPORTED THAT NOISE WAS OBSERVED ON MIFI CHANNELS. DURING AN CAVO-TRICUSPID ISTHMUS ABLATION PROCEDURE, AN INTELLANAV MIFI XP CATHETER WAS SELECTED FOR USE. NOISE WAS OBSERVED ON THE MIFI ELETROGRAMS. WHEN A MIFI CHANNEL WAS PACED, THE NOISE WOULD CLEAR UP. WHEN ANOTHER CHANNEL WAS SELECTED AND PACED, THAT NOISE WOULD CLEAR UP AND THE PREVIOUS CHANNEL WOULD AGAIN BECOME NOISY. THE NOISE WAS NOT RESOLVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING ADHESIVE SECTION BETWEEN THE TIP AND SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613051 ↗
• MalfunctionAug 20, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE CATHETER HAD CHAR FORMATION ON THE TIP OF THE ELECTRODE. AFTER AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI XP, THE CATHETER WAS REMOVED FROM THE BODY AND THE DOCTOR NOTICED THERE WAS CHAR FORMATION ON THE TIP OF THE ELECTRODE. THE PHYSICIAN ATTRIBUTED THIS TO THE SMALL INDENTATION THAT IS DESIGNED ON THE TIP OF THE ABLATION CATHETER. THE CATHETER WAS REPLACED FOR AN OI MIFI NAV CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8911224 ↗

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,