NC TREK NEO™ 1400375-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648232688), received between Dec 9, 2024 and Sep 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809227 ↗
• MalfunctionJan 8, 2026Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT THE DEVICE WAS RECEIVED AND THE INNER/OUTER MEMBER WAS SEPARATED. THE ACCOUNT STATED THAT THE SEPARATION OCCURRED WHEN THE STYLET WAS PULLED VERY HARD DURING PREP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006108 ↗
• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. AFTER IMPLANTING A 3X38MM XIENCE SKYPOINT STENT A 3.75X15MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED WITH RESISTANCE FELT WITH ANATOMY TO THE TARGET LESION. ONCE AT THE TARGET SITE THE BALLOON WAS INFLATED; HOWEVER, RUPTURED AT 8 ATMOSPHERES. NO OTHER BALLOON WAS USED AND PROCEDURE WAS NOTED TO BE COMPLETED THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547747 ↗
• MalfunctionDec 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE DISTAL LEFT CIRCUMFLEX ARTERY. THE 3.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878873 ↗