NC TREK 1012445-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648151668), received between May 23, 2019 and Jun 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL ARTERY. THERE WERE 16 BALLOONS USED IN THE PROCEDURE FOR DILATATION. HOWEVER, 8 OUT OF THE 16 BALLOONS USED HAD ISSUES. TWO NC TREK BALLOONS, 3.0X8MM AND 4.0X8MM, LOST PROFILE. FOUR NC TREK BALLOONS, 2.0X20MM, 2.5X15MM, 3.0X15MM AND 3.0X20MM, HAD BALLOON RUPTURES. ANOTHER 2 TREK BALLOONS, 2.25X12MM AND 2.5X15MM, ALSO HAD BALLOON RUPTURES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND 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 17127003 ↗
• MalfunctionOct 27, 2021Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 100% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY. THE 2X20MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED THROUGH THE GUIDE CATHETER (GC) WITH RESISTANCE MET, AND THE BDC BECAME KINKED. WHILE PULLING THE BDC BACK OUT OF THE GUIDE CATHETER, THE BALLOON SEPARATED FROM THE DELIVERY SYSTEM AND REMAINED IN THE GUIDE CATHETER. THE GUIDE CATHETER WAS REMOVED WITH THE SEPARATED DELIVERY SYSTEM AS ONE UNIT. ANOTHER SAME SIZE NC TREK BDC WAS USED TO SUCCESSFULLY DILATATE THE LESION WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706701 ↗
• MalfunctionMay 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN CORONARY LESION. WHEN THE NC TREK RX 2.0 X 20 MM DELIVERY SYSTEM WAS BEING LOADED ON THE GUIDE WIRE, THE PROXIMAL SHAFT BROKE IN TWO OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8638752 ↗