IntellaTip MiFi™ XP M004PM4500K20Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729848028), received between Dec 8, 2016 and Aug 24, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT WHILE USING AN INTELLANAV MIFI XP CATHETER, LOW TEMPERATURES WITH AN AVERAGE AROUND 20 C OCCURRED. NO ERROR MESSAGES OR ALERTS WERE NOTED. PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 ISSUE OCCURRED WHEN THE PHYSICIAN WAS ON ABLATION. THE TEMPERATURE ROSE TO THE TEMP LIMITER WHICH RESULTED IN LOW WATTAGE. THE GENERATOR WAS IN TEMPERATURE MODE. THE PHYSICIAN MOVED TO DIFFERENT POSITIONS TO TRY AND ESTABLISH BETTER COOLING. NO OTHER TROUBLESHOOTING WAS DONE. THE PHYSICIAN SWITCHED TO AN IRRIGATED OPEN IRRIGATED CATHETER. DEVICE WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287137 ↗
• MalfunctionJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JAN2018. IT WAS REPORTED THAT THE CATHETER STOPPED STEERING IN ONE DIRECTION. DURING AN ABLATION PROCEDURE TO TREAT RIGHT ATRIAL FLUTTER IN THE RIGHT ATRIUM WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE CATHETER STOPPED STEERING IN ONE DIRECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. DEVICE ANALYSIS REVEALED THE PROXIMAL SEAL OF RING 1 AND THE SEALS OF RING 2 WERE COMPROMISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216566 ↗
• MalfunctionJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11JAN2018. IT WAS REPORTED THAT THE CATHETER WOULD NO LONGER DEFLECT OR STEER. DURING AN ABLATION PROCEDURE TO TREAT RIGHT ATRIAL FLUTTER IN THE RIGHT ATRIUM WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE CATHETER DEFLECTION STOPPED WORKING MID-CASE AND WOULD NO LONGER STEER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT INCIDENT OR ISSUE TO PATIENT. DEVICE ANALYSIS REVEALED THE SEAL ON RING 1 AND RING 2 WERE COMPROMISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216555 ↗
• MalfunctionJan 12, 2018Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20DEC2017. IT WAS REPORTED THAT A BROKEN STEERING MECHANISM OCCURRED. DURING PREPARATION, THE INTELLATIP MIFI¿ XP ABLATION CATHETER WOULD NOT STEER IN EITHER DIRECTION. THE DEVICE WAS NEVER INSERTED INTO THE PATIENT. A NEW CATHETER WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH THAT DEVICE. NO PATIENT COMPLICATIONS OCCURRED. DEVICE ANALYSIS REVEALED BODY FLUID INGRESS THROUGH A NARROW SPLIT IN THE SEAL AT THE PROXIMAL EDGE OF RING 1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186703 ↗
• MalfunctionJan 9, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2017. IT WAS REPORTED THAT A TEMPERATURE SENSOR FAILURE ERROR (D06) OCCURRED. DURING AN ABLATION PROCEDURE, IN THE RIGHT ATRIUM, WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE TEMPERATURE SENSOR FAILED AND ERROR CODE D06 DISPLAYED. THE PHYSICIAN REPLACED THE CATHETER WITH A 10MM MIFI AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OCCURRED. DEVICE ANALYSIS REVEALED DRIED BODY FLUID UNDER THE RING 1 PROXIMAL SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7176148 ↗
• MalfunctionDec 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08DEC2017. IT WAS REPORTED THAT A TEMPERATURE SENSOR FAILED. DURING AN ABLATION PROCEDURE WITH AN INTELLATIP MIFI XP ABLATION CATHETER, A TEMPERATURE SENSOR FAILED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS OCCURRED. DEVICE ANALYSIS REVEALED BODY FLUID INGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138060 ↗
• MalfunctionDec 14, 2017Temperature Problem; Temperature Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28NOV2017. IT WAS REPORTED THAT POOR CATHETER TEMPERATURE CONTROL OCCURRED. DURING AN ABLATION PROCEDURE IN THE LEFT ATRIUM TO TREAT ATRIAL FLUTTER, AN INTELLATIP MIFI¿ XP ABLATION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER TIP FAILED TO ACHIEVE THE TARGETED POWER SETTINGS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS FINE. DEVICE ANALYSIS REVEALED ALL THREE RING SEALS WERE COMPROMISED AND THERE WAS DRIED BODY FLUID ON THE EDGE OF THE ELECTRODES. THERE WAS ALSO BODY FLUID UNDER R1 AND IN THE INTERIOR OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117329 ↗
• MalfunctionDec 14, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28NOV2017. IT WAS REPORTED THAT THE STEERING MECHANISM BROKE ON THE CATHETER. DURING AN ABLATION PROCEDURE IN THE RIGHT ATRIUM TO TREAT ATRIAL FLUTTER, AN INTELLATIP MIFI XP ABLATION CATHETER WAS SELECTED FOR USE AND THE CURVE ON THE CATHETER BROKE. THERE WERE NO COMPLICATIONS AND THEY COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. DEVICE ANALYSIS REVEALED THE RING 1 SEALS WERE COMPROMISED; THERE WAS DRIED BODY FLUID ON THE EDGE OF THE ELECTRODE. THERE WAS ALSO BODY FLUID IN THE INTERIOR OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117198 ↗
• MalfunctionNov 21, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31OCT2017. IT WAS REPORTED THAT THE CURVE ON THE CATHETER BROKE. DURING AN ATRIAL FLUTTER ABLATION PROCEDURE IN THE RIGHT ATRIUM WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE CURVE ON THE ABLATION CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. DEVICE ANALYSIS REVEALED THAT THE RING 1 (R1) SEALS WERE COMPROMISED AND THERE WAS BODY FLUID UNDER R1 AND IN THE INTERIOR OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047985 ↗
• MalfunctionOct 2, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18SEPT2017. IT WAS REPORTED THE STEERING MECHANISM OF THE CATHETER BROKE. THE INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS SELECTED FOR TREATMENT OF RIGHT ATRIAL FLUTTER. IT WAS NOTED THAT THE STEERING MECHANISM BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER DEVICE ANALYSIS FOUND ELECTRODE RING 1 AND RING 2 SEALS WERE COMPROMISED. BODY FLUID WAS FOUND UNDER RING 1, AND IN THE INTERIOR OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907111 ↗
• MalfunctionJun 20, 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 PATIENT COMPLICATIONS WERE REPORTED. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED THE SEAL OF ALL RING 1 IS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6653027 ↗
• MalfunctionJun 15, 2017Break; Break

  REPORTABLE BASED ON ANALYSIS COMPLETED MAY 23, 2017. IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER PROCEDURE, AN INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS ADVANCED INTO THE RIGHT ATRIUM. DURING THE PROCEDURE THE STEERING MECHANISM BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE SEAL ON RING 1 WAS COMPROMISED AND THERE WERE BODY FLUIDS UNDER THE RING AND IN THE INTERIOR OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643025 ↗
• MalfunctionApr 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 21 APRIL 2017. IT WAS REPORTED IT BECAME STIFF AND THE STEERING MECHANISM STOPPED WORKING. ATRIAL FIBRILLATION ABLATION WAS ATTEMPTED USING A INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER. DURING THE PROCEDURE THE DEVICE BECAME STIFF AND THE STEERING MECHANISM STOPPED WORKING, SO IT WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS FINE. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED THE SEAL OF RING 1 IS COMPROMISED AND A CUT IN THE DISTAL INSULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515573 ↗
• MalfunctionJan 4, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07DEC2016. IT WAS REPORTED THAT THE CURVE ON THE CATHETER WOULD NO LONGER DEFLECT. DURING AN ABLATION PROCEDURE IN THE RIGHT ATRIUM WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE CURVE ON THE CATHETER WOULD NO LONGER DEFLECT AND BROKEN STEERING WIRE WAS SUSPECTED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS FINE. DEVICE ANALYSIS REVEALED BODY FLUID UNDER ALL THREE RINGS NEAR THE WIRE OPENING IN THE SHAFT AND BODY FLUID IN THE INTERIOR OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6221151 ↗
• MalfunctionDec 22, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2016. IT WAS REPORTED THAT A "SENSOR FAILURE" MESSAGE "D08" OCCURRED. DURING AN ABLATION PROCEDURE WITH A INTELLATIP MIFI XP ABLATION CATHETER, THEY HAD A "SENSOR FAILURE" MESSAGE "D08" ON THE MAESTRO. THE PHYSICIAN REPLACED THE CATHETER AND THEY WERE ABLE TO FINISH THE CASE. THERE WERE NO ADVERSE IMPACTS TO THE PATIENT. DEVICE ANALYSIS REVEALED DRIED BODY FLUID UNDER THE R2 SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6198414 ↗
• MalfunctionDec 14, 2016Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED NOVEMBER 22, 2016. IT WAS REPORTED THAT THE STEERING WIRE BROKE. AN INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS SELECTED AND ADVANCED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS NO LONGER ABLE TO BE DEFLECTED IN A BIDIRECTIONAL MANNER. THE CATHETER WAS EXCHANGED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE RING SEALS WERE COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6173650 ↗
• MalfunctionDec 13, 2016Break; Break

  REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED NOVEMBER 22, 2016 IT WAS REPORTED THAT THE STEERING WIRE BROKE. AN INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER WAS SELECTED AND ADVANCED FOR USE. DURING THE PROCEDURE, THE CATHETER WOULD NO LONGER CURVE IN ONE DIRECTION. THE CATHETER WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE RING SEAL WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6171217 ↗
• MalfunctionDec 8, 2016Break; Break

  REPORTABLE BASED ON ANALYSIS COMPLETED NOVEMBER 16, 2016. IT WAS REPORTED THAT THE CURVE WOULD NOT CURVE. THE PROCEDURE WAS INDICATED FOR ATRIAL FLUTTER ABLATION. THE INTENDED LOCATION WAS THE RIGHT ATRIUM. AN INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS USED. FOLLOWING USE, THE CURVE WOULD NOT CURVE. IT WAS SUSPECTED THAT THE STEERING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. RETURNED DEVICE ANALYSIS REVEALED THE RING SEAL WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6155293 ↗

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,