NC TREK 1012447-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648151736), received between Jan 13, 2020 and Nov 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 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.

• MalfunctionNov 9, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT FOLLOWING PREPPING AND FLUSHING THE DEVICE, THE YELLOW PROTECTIVE SHEATH OF THE 2.5X6.0MM NC TREK BALLOON DILATATION CATHETER (BDC) COULD NOT BE REMOVED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A 2.50X15MM NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781290 ↗
• MalfunctionJan 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS DE NOVO RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. THE 2.50X6MM RX NC TREK BALLOON RUPTURED AT 6 ATMOSPHERES ON THE FIRST INFLATION. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582249 ↗