NC TREK NEO™ 1400375-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648232695), received between Feb 24, 2026 and Feb 24, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED MID LEFT CIRCUMFLEX LESION. A 3.75X20 MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED PRIOR TO PATIENT USE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION. HOWEVER, AFTER ONE INFLATION AT 12 ATM, THE BALLOON COMPLETELY FAILED TO DEFLATE DESPITE MULTIPLE ATTEMPTS AND WAS WITHDRAWN INFLATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436049 ↗