IntellaNav MiFi Open-IrrigatedRecalls & reported problems across all models

We found 3 models of IntellaNav MiFi Open-Irrigated by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 395 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Oct 22, 2025 — classified as 4 deaths, 65 injuries, 326 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (108 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported IntellaNav MiFi Open-Irrigated problems

IntellaNav MiFi Open-Irrigated models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IntellaNav MiFi™ Open-Irrigated M004PMR96200

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  4 deaths269 reports
• IntellaNav MiFi™ Open-Irrigated M004PMR9620K20

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  78 reports
• IntellaNav MiFi™ Open-Irrigated M004PMR9620N40

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  48 reports

Recent IntellaNav MiFi Open-Irrigated adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON SEPTEMBER 24, 2025. IT WAS REPORTED THAT NOISE SIGNAL INTERFERENCE OCCURRED INTERMITTENTLY. AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS USED FOR RADIOFREQUENCY ABLATION OF SUPRAVENTRICULAR TACHYCARDIA PROCEDURE IN THE ATRIOVENTRICULAR NODE. DURING THE PROCEDURE, A NOISE SIGNAL INTERFERENCE OCCURRED INTERMITTENTLY, AND IT AFFECTED POTENTIAL JUDGMENT. THE DEVICE WAS REPLACED AND COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN OBSTRUCTION ON THE DISTAL END WAS NOTED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358833 ↗
• MalfunctionApr 14, 2025Fluid/Blood Leak; Improper Flow or Infusion; Material Integrity Problem; Fluid/Blood Leak; Improper Flow or Infusion; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO FLUSH PROPERLY AND THE FLUSH PORT ON THE ABLATION CATHETER WAS BROKEN. DURING AN ABLATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION AND ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT), AN INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE. THE CATHETER WAS CONNECTED TO THE CATHETER CONNECTION CABLE AND METRIQ TUBING; HOWEVER, IT WAS OBSERVED THAT IT WAS UNABLE TO FLUSH PROPERLY. IT WAS NOTED THAT THE FLUSH PORT ON THE ABLATION CATHETER WAS BROKEN. ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836773 ↗
• MalfunctionDec 10, 2024Connection Problem; Connection Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT DURING A LEFT SIDE BYPASS PROCEDURE, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. ABOUT 30 MINUTES INTO THE PROCEDURE, THERE WAS IMPEDANCE AND POTENTIAL, HOWEVER THE CATHETER COULD NOT SHOW THE IMAGE. NO ERROR MESSAGES DISPLAYED. AFTER THE CATHETER WAS CONNECTED TO THE TAIL LINE, IT ENTERED THE VENTRICLE. THE IMPEDANCE AND POTENTIAL WERE NORMAL; HOWEVER, THE IMAGE COULD NOT BE SHOWN. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE WAS RETURNED FOR ANLAYSIS. DEVICE ANALYSIS REVEALED THAT THE DEVICE'S TIP HAD DETACHED/SEPARATED IN THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898719 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A STROKE, CONFUSION, FEVER AND A FISTULA THAT REQUIRED ADDITIONAL SURGERY. ON (B)(6) 2024, A NAV MIFI OI CATHETER WAS SELECTED FOR A CARDIAC ABLATION PROCEDURE TO TREAT THE POSTERIOR WALL. ON (B)(6) 2024 THE PATIENT PRESENTED WITH A STROKE, CONFUSION, AND FEVER. COMPUTED TOMOGRAPHY (CT) IMAGING WAS PERFORMED AND CONFIRMED THAT AN ATRIO-ESOPHAGEAL (AE) FISTULA. SURGICAL INTERVENTION WAS PERFORMED TO REPAIR THE AE FISTULA. THE PATIENT HAS BEEN HOSPITALIZED FOR TREATMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

  Patient problems: Confusion/ Disorientation; Fever; Fistula; Stroke/CVA

  MAUDE report 20710120 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA & DISSECTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT REQUIRED STENTING. AN INTELLANAV MIFI OI CATHETER WAS SELECTED FOR A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE. DURING MAPPING NEAR THE CORONARIES, A TACHYCARDIA WAS NOTICED WITH DECREASED LV FUNCTION AS SEEN ON IMAGING. THE NAV MIFI OI CATHETER WAS CATHETER WAS REMOVED, AND A DISSECTION WAS OBSERVED WITHIN THE LAD. THE DISSECTION WAS TREATED BY AN INTERVENTIONAL CARDIOLOGIST WITH STENT PLACEMENT. PATIENT WAS ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE AND IS CURRENTLY RECOVERING.

  Patient problems: Tachycardia; Vascular Dissection

  MAUDE report 20663544 ↗
• MalfunctionNov 8, 2024Temperature Problem; Temperature Problem

  DURING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION PROCEDURE, A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TEMPERATURE SENSOR OF THE DEVICE WAS DAMAGED, AND THE TEMPERATURE OF THE DEVICE IN THE BODY WAS ABNORMAL. NO ERROR MESSAGE WAS DISPLAYED. THE DEVICE HAS BEEN REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643385 ↗
• MalfunctionNov 7, 2024Temperature Problem; Temperature Problem

  DURING ABLATION PROCEDURE, A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT AN INACCURATE TEMPERATURE SENSING / UNABLE TO SENSE TEMPERATURE ISSUE OCCURRED. NO SPECIFIC ERROR MESSAGE WAS MENTIONED OR DISPLAYED. THE DEVICE HAS BEEN REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634852 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT THE FLUSH PORT POPPED OFF MID-PROCEDURE. THE DEVICE WAS REPLACED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340290 ↗
• MalfunctionSep 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT UPON OPENING THE BOX THEY OBSERVED A SMALL TEAR IN THE DEVICE PLASTIC PACKAGING RESULTING IN COMPROMISED STERILITY. THE DEVICE WAS REPLACED WITH A NEW ONE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233118 ↗
• MalfunctionSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS RETURNED WITHOUT A RELATED COMPLAINT RECORD. INVESTIGATION WAS PERFORMED ON DEVICE AND REVEALED THE TIP WAS OBSTRUCTED AFFECTING THE FLOW INSIDE OF THE DEVICE AS WELL AS THE TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217643 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE INTELLANAV OPEN IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT ATRIAL FLUTTER. IT WAS REPORTED THAT 'D05-EXCESSIVE TEMPERATURE' ERROR APPEARED ON THE MAESTRO GENERATOR AFTER MAPPING AND ABLATION IN THE LEFT ATRIUM AND LEAKAGE WAS OBSERVED ON THE CATHETER'S IRRIGATION PORT AROUND THE TUBING. IT WAS NOTED THERE WAS NO DAMAGE ON THE LUER ITSELF. REPLACING THE CATHETER RESOLVED THE ISSUE. 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 20019580 ↗
• MalfunctionAug 14, 2024Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Data Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT A SUPRAVENTRICULAR TACHYCARDIA (SVT), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. THE MAGNETIC SENSOR OF THE CATHETER MIGHT HAVE BEEN DAMAGED, ON THE SYSTEM THE CATHETER IMAGE WAS ABNORMAL, THE SIGNAL WAS UNSTABLE AND FINALLY WAS LOST, NO ERROR MESSAGES WERE DISPLAYED. PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT AND HAD TO BE CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982780 ↗
• MalfunctionJul 31, 2024Failure to Deliver Energy; Defective Device; Failure to Deliver Energy; Defective Device

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT RADIOFREQUENCY ABLATION WAS NOT POSSIBLE DUE TO DEVICE FAILURE AND THE PROCEDURE WAS STOPPED. NO DAMAGE AND NO PATIENT COMPLICATIONS WERE NOTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19872207 ↗
• MalfunctionJul 18, 2024Improper Flow or Infusion; Temperature Problem; Improper Flow or Infusion; Temperature Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FLUTTER IN THE CAVOTRICUSPID ISTHMUS (CTI), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. CATHETER PRESENTED IRRIGATION ISSUES AND HAD INACCURATE TEMPERATURE SENSING. CATHETER WAS TAKEN OUT OF THE BODY TO DOUBLE CHECK FLOW AND NOTHING WAS OCCLUDED. TRIED AGAIN AND GOT SAME ERROR. ALL PUMP SETTINGS WERE ON RIGHT; HOWEVER, PUMP WAS NOT INCREASING SPEED OF IRRIGATION WHEN ABLATION CAME ON. UNPLUGGED AND REPLUGGED ALL CONNECTIONS AND REPLACED THE PUMP; NEVERTHELESS, THE ISSUE PERSISTED. IT WAS DECIDED TO CHANGE THE IRRIGATED CATHETER FOR A INTELLANAV MIFI XP NON IRRIGATED CATHETER. AFTER THAT, A "SET POWER" ERROR WAS SEEN ON THE MAESTRO GENERATOR, EVEN THOUGH POWER WAS ALREADY SET. FINALLY, IT WAS DECIDED TO SWITCH OUT THE POD AND THAT RESOLVED THE PROBLEM. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773851 ↗
• MalfunctionJul 10, 2024Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem; Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHILE ATTEMPTING TO DELIVER RF ENERGY, THE GENERATOR GAVE A HIGH TEMP ERROR AND THE PHYSICIAN REALIZED THE FLUSH TUBING HAD SNAPPED OFF FROM THE CATHETER HANDLE AND STARTED LEAKING. THE DEVICE WAS REPLACED WITH A NEW CATHETER AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS NOT EXPECTED TO BE RETURNED SINCE IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712395 ↗

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