IntellaTip MiFi™ XP M004PM45000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729848011), received between Dec 13, 2016 and Jul 16, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION (PAF), AN INTELLATIP MIFI XP CATHETER WAS SELECTED FOR USE. AFTER SEVERAL INSTANCES OF ENERGIZING, THE CATHETER TIP BECAME DEFORMED DUE TO HEAT DAMAGE, MAKING IT DIFFICULT TO MAINTAIN PROPER CONTACT. CATHETER WAS REPLACED 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 DISCARDED AT FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756422 ↗
• InjuryApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP DETACHED FROM THE REST OF THE CATHETER AND WAS UNABLE TO BE RETRIEVED, WHICH REQUIRED A SURGICAL INTERVENTION. PER LITERATURE REVIEW, IT WAS REPORTED THAT: A 52-YEAR-OLD MAN TREATED WITH PREVIOUS MECHANICAL MITRAL VALVE REPLACEMENT PRESENTED TO AN OUTSIDE HOSPITAL FOR PLANNED CARDIAC ABLATION FOR ATRIAL FIBRILLATION (AF) USING AN INTELLATIP MIFI XP ABLATION CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE INTELLATIP ABLATION CATHETER ACROSS THE MECHANICAL MITRAL VALVE, THE CATHETER WAS SHEARED, LEAVING THE DISTAL TIP INTRAVASCULARLY AND UNABLE TO BE RETRIEVED. HE WAS EMERGENTLY TRANSFERRED TO THE ADVOCATE HEALTH CARE FACILITY, UNITED STATES, FOR FURTHER WORKUP AND TREATMENT. ON ARRIVAL, WORKUP INCLUDING CHEST X-RAY, ABDOMINAL X-RAY AND NECK X-RAY FAILED TO REVEAL THE RETAINED CATHETER TIP. THEREFORE, A SKULL X-RAY WAS PERFORMED AND THEN CONFIRMED WITH HEAD COMPUTED TOMOGRAPHY (CT) SHOWING THE CATHETER TIP PRESENT IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT ARRIVED NEUROLOGICALLY INTACT WITH ONLY SYMPTOMS OF A MILD HEADACHE. DUE TO CONCERNS OF DEVELOPING A LARGE VESSEL OCCLUSION, PATIENT WAS EMERGENTLY TAKEN TO THE NEUR

  Patient problems: Headache

  MAUDE report 19041723 ↗
• MalfunctionOct 17, 2022Temperature Problem; Temperature Problem

  DURING PROCEDURE, AN INTELLATIP MIFI XP CATHETHER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TEMPERATURE COULD NOT BE DETECTED. AFTER CATHETER WAS INSERTED, ENERGIZATION WAS STARTED AT 50W55 DEGREES SETTING, BUT TEMPERATURE REMAINED AT 36 DEGREES, AND IT DID NOT INCREASE. CATHETER WAS APPLIED AND GENERATOR WAS RESTARTED, BUT THERE WAS NO IMPROVEMENT, SO THE CATHETER WAS REPLACED, AND IT IMPROVED. PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618922 ↗
• MalfunctionAug 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A STEAM POP OCCURRED. A INTELLATIP MIFI XP WAS USED IN A SUPRAVENTRICULAR TACHYCARDIA ABLATION. ON THE THIRD ABLATION DELIVERY THE PHYSICIAN EXPERIENCED A STEAM POP. PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784098 ↗
• MalfunctionJan 17, 2018Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22DEC2017. IT WAS REPORTED THAT THE STEERING MECHANISM BROKE. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE PHYSICIAN SUSPECTED A STEERING WIRE BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. DEVICE ANALYSIS REVEALED THAT THE SEALS OF ALL THREE RINGS HAD BEEN COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7200255 ↗
• MalfunctionDec 13, 2017Kinked; Kinked

  REPORTABLE BASED ON ANALYSIS COMPLETED NOVEMBER 28TH, 2017. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER, WHILE HEATING THE ISTHMUS AFTER INSERTING INTO THE SHEATH, IT WAS OBSERVED THAT THE TIP OF THE INTELLATIP MIFI¿ XP ABLATION CATHETER WAS KINKED. THE CATHETER WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE SEAL ON RING 1 WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112515 ↗
• MalfunctionOct 5, 2017Break; Break

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT THE CATHETER STEERING MECHANISM BROKE. RIGHT ATRIAL FIBRILLATION ABLATION WAS ATTEMPTED USING A INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER. DURING ABLATION THE CATHETER STEERING MECHANISM BROKE, SO IT WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED THE SEAL OF RING 1 IS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6917665 ↗
• MalfunctionJun 20, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL ON THE DEVICE WAS NOTED. AN INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS SELECTED. WHEN THE DEVICE WAS UNPACKED FROM THE HANDLE PART, SILICONE DUST AND SOME FRAGMENTS WERE FOUND AT THE SIDE OF THE CATHETER. THE DEVICE WAS NOT USED AND WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6652955 ↗
• MalfunctionDec 13, 2016Break; Break

  REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED NOVEMBER 22, 2016. IT WAS REPORTED THAT THE STEERING WIRE BROKE. THE PROCEDURE WAS INDICATED FOR AN ATYPICAL FLUTTER ABLATION/REDO AFIB. AN INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS SELECTED AND ADVANCED. TOWARDS THE END OF THE PROCEDURE, THE PHYSICIAN FELT AS IF THE STEERING WIRE BROKE AS HE WAS ONLY ABLE TO STEER THE CATHETER IN ONE DIRECTION. THE PROCEDURE WAS COMPLETE WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE IN THE SHEATH AND THE RING SEALS WERE COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6171967 ↗

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,