NC TREK NEO™ 1400500-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648232817), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• InjuryOct 14, 2024Difficult to Insert; Loose or Intermittent Connection; Difficult to Remove; Difficult to Insert; Loose or Intermittent Connection; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED LESION IN THE LEFT MAIN CORONARY ARTERY WITH MODERATE CALCIFICATION. THE 5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE. HOWEVER, THE HUB OF THE BDC WAS NOTED TO BE VERY ROBUST AND DIFFICULTY WAS NOTED WHEN FITTING THE PRESSURE GAUGE SYRINGE. AFTER THE BALLOON WAS INFLATED, THE PROFILE WAS FOUND TO BE HIGH MAKING IT DIFFICULT TO RETRACT THE BDC INTO THE GUIDE CATHETER. AFTER BALLOONING A LEAK IN THE LEFT ANTERIOR DESCENDING (LAD) WAS NOTED AND A PERICARDIAL EFFUSION WAS CONFIRMED. SURGERY WAS PERFORMED TO DRAIN THE PERICARDIAL EFFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 20447152 ↗