IntellaTip MiFi™ XP M004PM4790K20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729848059), received between Dec 15, 2016 and Oct 27, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Bent” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE A PROCEDURE AN INTELLATIP MIFI XP CATHETER WAS SELECTED FOR USE, HOWEVER, THE DEVICE WAS FOUND CONTAMINATED WITH A FOREIGN SUBSTANCE. THE FOREIGN MATERIAL WAS CONTAINED INSIDE THE STERILE BARRIER. THE FOREIGN MATERIAL WAS LOOSE. IT WAS DECIDED TO REPLACE THE DEVICE, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021082 ↗
• MalfunctionJun 13, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE USING A INTELLATIP MIFI XP CATHETER THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING. THEY REPLACED THE CATHETER AND WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676218 ↗
• InjuryNov 3, 2021Noise, Audible; Noise, Audible

  DURING A CAVO-TRICUSPID ISTHMUS (CTI) LINE ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION A INTELLATIP MIFI XP CATHETER WAS SELECTED FOR USE. THE SYSTEM WAS OPERATING AT DEFAULT SETTINGS AND THE TEMPERATURE CONTROL WAS AT 70 WATTS AND 65 DEGREES. AFTER CTI BLOCK WAS CONFIRMED, IT WAS REPORTED THAT A STEAM POP OCCURRED DURING THE EXTRA ABLATION INSIDE THE CTI INFERIOR VENA CAVA. CARDIAC TAMPONADE WAS ALSO OBSERVED. THE PROCEDURE WAS COMPLETED WITH TREATMENT.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Necrosis; Pericardial Effusion

  MAUDE report 12747290 ↗
• MalfunctionJun 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGE. DURING PREPARATION OF THE INTELLATIP MIFI¿ XP ABLATION CATHETER, AN OBJECT WHICH APPEARED TO BE ¿TRASH¿ WAS FOUND INSIDE THE STERILE INNER PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592829 ↗
• MalfunctionMay 3, 2018Signal Artifact/Noise; Bent; Signal Artifact/Noise; Bent

  THIS EVENT IS REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED 4/6/18. IT WAS REPORTED THAT UPON ABLATION IN THE RIGHT ATRIUM, NOISE APPEARED ON THE 1-2 BIPOLAR DISPLAY. IT WAS NECESSARY TO REPLACE THE CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED. IT WAS ALSO NOTED THAT THE TIP OF THE CATHETER WAS BENT OUT OF THE BOX. DEVICE ANALYSIS REVEALED A COMPROMISED SEAL ON RING 1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7483456 ↗
• MalfunctionDec 20, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29NOV2017. IT WAS REPORTED THAT A INTELLATIP MIFI¿ XP WAS SELECTED FOR A CAVO-TRICUSPID ISTHMUS(CTI) ABLATION. WHEN THE CATHETER WAS USED THE PULL WIRE GOT BROKEN, SO THE CATHETER ONLY BENT ON ONE SIDE. IT WAS REPLACED WITH ANOTHER OF SAME DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER ANALYSIS OF THE DEVICE REVELED A COMPROMISED RING SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133999 ↗
• MalfunctionJan 26, 2017Bent; Bent

  REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED JANUARY 12, 2017. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF A INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE RING SEAL WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278695 ↗
• MalfunctionDec 15, 2016No Device Output; No Device Output

  IT WAS REPORTED THAT NO SIGNAL OCCURRED. AFTER POSITIONING THE INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER IN THE PATIENT, THE CABLE WAS CONNECTED; HOWEVER THE ELECTRIC POTENTIAL WAS NOT DISPLAYED. CHANGING THE CABLE DID NOT RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER TO ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE RING SEAL WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6178249 ↗

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,