IntellaTip MiFi™ XP M004PM47900Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729848042), received between Jan 9, 2018 and Jun 21, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionJun 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND INSIDE THE STERILIZATION BAG AFTER UNPACKING THE BOX CONTAINING THE INTELLATIP MIFI CATHETER. WHEN THE BAG WAS CHECKED CLOSELY, THERE WERE PLASTIC PIECES FOUND. SINCE THE COATING OF THE MAIN UNIT HANDLE PEELED OFF, IT IS POSSIBLE THAT IT WAS PART OF THE PLASTIC PIECES. NO PATIENT COMPLICATIONS WERE REPORTED. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032055 ↗
• MalfunctionJun 4, 2019Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20MAY2019. IT WAS REPORTED THE CATHETER COULD NOT BE RECOGNIZED. DURING AN ABLATION PROCEDURE WITH AN INTELLATIP MIFI XP CATHETER WHEN THE ABLATION CATHETER WAS PLACED IN THE HEART, THE CATHETER COULD NOT BE RECOGNIZED. RECOGNITION WAS IMPROVED BY CHECKING THE CONNECTION AND STARTING UP THE EQUIPMENT, BUT IMPEDANCE WAS HIGH, AND ENERGIZATION COULD NOT BE PERFORMED. CONNECTION CHECKING, EQUIPMENT STARTING UP, AND CONNECTION CABLE REPLACEMENT WERE PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. IT WAS REQUESTED TO REPLACE TO ABLATION CATHETER, BUT SINCE IT ALREADY TOOK TIME, THE PHYSICIAN TOLD TO PERFORM THE PROCEDURE USING NON-BSC SYSTEM ABLATION CATHETER, AND THAT WAS FOLLOWED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE ANALYSIS REVEALED RINGS WERE INSPECTED AND RING #1 SEAL WAS FOUND COMPROMISED SINCE BROKEN ADHESIVE WAS OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666177 ↗
• MalfunctionMar 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK FOREIGN OBJECT WAS FOUND INSIDE THE STERILE CATHETER PACKAGING. DURING PREPARATION FOR AN ATRIAL FLUTTER ABLATION PROCEDURE, A BLACK FOREIGN OBJECT WAS FOUND INSIDE THE STERILE CATHETER PACKAGING. THE DEVICE WAS NOT USED FOR THE PROCEDURE AND ANOTHER OF THE SAME CATHETER WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420025 ↗
• MalfunctionFeb 21, 2018Insufficient Heating; Insufficient Heating

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ABLATE. A INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS SELECTED FOR A ATRIAL FLUTTER(AFL) ABLATION. HOWEVER ABLATION WAS PERFORMED WITH 60W AND 60 DEGREES SETTINGS, BUT WHILE THE W INCREASED, THE TEMPERATURE DID NOT INCREASE MORE THAN ABOUT 40 DEGREES, AND IT DID NOT CHANGE WITHOUT REDUCING THE POTENTIAL OF THE MINI ELECTRODE OF MIFI. ABLATION WAS PERFORMED FOR ABOUT 15 TIMES, THE PROCEDURE WAS COMPLETED WITH ANOTHER INTELLATIP MIFI. NO COMPLICATIONS WERE REPORTED. HOWEVER ANALYSIS REVELED BROKEN RING SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285931 ↗
• MalfunctionJan 9, 2018Bent; Positioning Problem; Bent; Positioning Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2017. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER, THE INTELLATIP MIFI¿ XP ABLATION CATHETER WAS NOT ABLE TO COME IN CONTACT PROPERLY WITH THE TARGET AREA, AND ¿THE POTENTIAL DID NOT ATTENUATE EVEN THOUGH ENERGIZATION WAS PERFORMED.¿ THE CATHETER WAS REMOVED AND ¿THE ELECTRODE PART OF NO. 3-4¿ WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE SEALS ON RING 1 AND RING 2 WERE COMPROMISED AND A PIECE OF THE RING 1 SEAL WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175910 ↗

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,