NC TREK 1012450-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648151941), received between Mar 1, 2017 and Dec 29, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION AND 90% STENOSIS. THE 3.25X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) COULD NOT CROSS THE LESION AND THE SHAFT SEPARATED DISTALLY INTO THE GUIDING CATHETER. THE ENTIRE SYSTEM WAS REMOVED TO REMOVE THE SEPARATED PIECE AND THE PROCEDURE WAS COMPLETED WITH A NEW NC TREK BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907858 ↗
• MalfunctionNov 17, 2023Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CALCIFIED LESIONS IN THE MIDDLE AND DISTAL THIRD RIGHT CORONARY ARTERY (RCA). THE HI-TORQUE 014 BMW GUIDEWIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, THE GW WOULD NOT ALLOW THE ADVANCEMENT OF A 2.0 MINI TREK BALLOON DILATATION CATHETER (BDC) AND A 3.25X20MM NC TREK BDC. WHEN ATTEMPTING TO ADVANCE EACH BDC, RESISTANCE WAS MET WITH THE GW AND THE SHAFT BECAME STRETCHED AND BROKE ON EACH BDC. THE GW WAS EXCHANGED FOR A HI-TORQUE 014 BHW GW, WHICH WAS ALSO NOTED TO HAVE DIFFICULTY WHEN ADVANCING OTHER DEVICES. TWO DRUG-ELUTING STENTS WERE IMPLANTED TO COMPLETE THE PROCEDURE. 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 18163980 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED VESSEL. PRIOR TO USE OF THE NC TREK BALLOON DILATATION CATHETER (BDC), IT WAS NOTED TO BE BROKEN AND NOT POSSIBLE TO BE USED. ANOTHER ABBOTT BALLOON 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 14549043 ↗
• MalfunctionNov 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 3.25X20MM NC TREK BALLOON WAS BEING ADVANCED THROUGH A NON-ABBOTT GUIDE CATHETER, WHEN IT WAS NOTED THAT THE PROXIMAL SHAFT BROKE IN TWO. THE DEVICE WAS SIMPLY WITHDRAWN. ANOTHER BALLOON WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12883777 ↗
• InjuryOct 16, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE 3.25X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND MET RESISTANCE WITH THE HEAVILY CALCIFIED AND TORTUOUS ANATOMY. THE NC TREK WAS INFLATED TWICE AT 12 ATMOSPHERES OF PRESSURE. A PERFORATION OCCURRED IN THE LAD AFTER THE BALLOON RUPTURE. THE 3.5X16 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS INSERTED, BUT IT WAS UNABLE TO CROSS THE VESSEL DUE TO THE PATIENT ANATOMY. THE 2.8X16 MM GRAFTMASTER SDS WAS INSERTED AND WAS SUCCESSFULLY IMPLANTED; HOWEVER, THIS 2.8X16 SIZE WAS USED AFTER THE LABELED EXPIRATION DATE. THE PERFORATION WAS SEALED. THE PATIENT HAS NOT HAD ANY ADVERSE REACTIONS TO THE EXPIRED GRAFTMASTER STENT. THIS WAS USED BECAUSE IT WAS THE ONLY UNIT AVAILABLE AND IT WAS A LIFE THREATENING SITUATION FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 10693492 ↗
• MalfunctionFeb 6, 2018Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.25 X 20MM NC TREK BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE INFLATED, BUT WAS UNSUCCESSFUL. THE DEVICE WOULD NOT INFLATE. ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 7246296 ↗
• MalfunctionApr 7, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, LESION IN THE RIGHT CORONARY ARTERY. WHEN ADVANCING THE 3.25X20MM NC TREK BALLOON DILATATION CATHETER (BDC) OVER A 0.014 BMW GUIDE WIRE, THE PROXIMAL SHAFT SEPARATED. THE NC TREK DID NOT ENTER THE PATIENT ANATOMY. AN UNSPECIFIED NC TREK WAS ABLE TO BE ADVANCED OVER THE SAME BMW GUIDE WIRE 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 6473545 ↗
• MalfunctionMar 1, 2017Break; Stretched

  IT WAS REPORTED THAT THE TRANSITION BETWEEN THE BALLOON AND THE SHAFT [PROXIMAL SEAL] OF THE 3.25X20 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS STRETCHED. THE DEVICE WAS NOT USED, NO PATIENT INVOLVEMENT. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED A PROXIMAL BALLOON MARKER/ INNER MEMBER SEPARATION.

  Patient problems: No Patient Involvement

  MAUDE report 6369943 ↗