NC TREK 1012449-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648151897), received between Feb 24, 2017 and Dec 13, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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 16, 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.

• InjuryDec 13, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THERE WAS RESISTANCE DURING REMOVAL OF THE 3.0 X 25 MM NC TREK BALLOON DILATION CATHETER (BDC) DUE TO THE ANATOMY WHEN THE DISTAL END OF THE BDC BECAME DETACHED. AN UNSPECIFED STENT WAS DEPLOYED TO EMBED THE DETACHED PORTION OF THE BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 9465741 ↗
• MalfunctionJul 25, 2019Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, THE NC TREK RX BALLOON WAS OVER-INFLATED AND RUPTURED OUTSIDE THE PATIENT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER NC TREK RX WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8827798 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component

  IT WAS REPORTED THAT A 3.0 X 25MM NC TREK BALLOON DILATATION CATHETER WAS PREPPED ACCORDINGLY, HOWEVER, AFTER PREP IT WAS NOTED THAT THE PROXIMAL (SHAFT) WAS BROKEN INTO TWO PIECES AT ABOUT 10 CM. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER SAME SIZE NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7290844 ↗
• MalfunctionFeb 24, 2017Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THAT THE 3.0X25 NC TREK WAS BEING ADVANCED AROUND A BEND IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS DIAGONAL CORONARY ARTERY FOR POST DILATATION OF A XIENCE WHEN THE MIDDLE OF THE SHAFT SEPARATED. THE SEPARATED SHAFT WAS REMOVED MANUALLY AND ANOTHER NC TREK WAS USED TO 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 6358642 ↗