NC TREK NEO™ 1400400-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648232732), received between Aug 27, 2024 and Apr 9, 2025 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN UNKNOWN VESSEL. THE 4.00X20MM NC TREK NEO CORONARY DILATATION CATHETER WAS ADVANCED OVER AN UNSPECIFIED 0.014" GUIDEWIRE. A REFLUX OF BLOOD WAS OBSERVED IN AN UNSPECIFIED INDEFLATOR AND THE NC TREK NEO WAS NOT USED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21807264 ↗
• MalfunctionAug 27, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 4X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE AND THE BALLOON WAS INFLATED TO 24 ATMOSPHERES (ATM) THREE TIMES; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED. IN THE SAME PROCEDURE A 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER WAS USED AND THE BALLOON WAS INFLATED TO 20 ATM TWICE, THE SECOND BALLOON ALSO WOULD ONLY PARTIALLY DEFLATE. DIFFERENT DEFLATION SYRINGES WERE USED IN AN ATTEMPT TO DEFLATE THE BALLOONS. BOTH BALLOONS WERE ULTIMATELY DEFLATED AND WERE REMOVED WITH A HIGH DEGREE OF FRICTION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078880 ↗