NC TREK™ 1012446-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648151682), received between Dec 15, 2017 and Apr 28, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED DE NOVO LESION IN THE RIGHT POSTERIOR DESCENDING ARTERY. PRE-DILATATION WAS BEING PERFORMED WITH A 2.25X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT AROUND 5 ATMOSPHERES. PRE-DILATATION WAS COMPLETED WITH A 2.25X10MM NON-ABBOTT BDC AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A 2.5X15MM XIENCE SIERRA STENT. 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 10007987 ↗
• MalfunctionDec 19, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED LEFT CIRCUMFLEX CORONARY ARTERY. A 2.25X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS TO BE USED FOR PRE-DILATATION BUT FELT RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION, AND THE BDC WAS REMOVED WITHOUT RESISTANCE. A 2X15MM TREK BDC AND A 2.25X20 NON-ABBOTT STENT WERE USED TO SUCCESSFULLY COMPLETE HE 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 9497255 ↗
• MalfunctionApr 22, 2019Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING ADVANCEMENT, RESISTANCE WAS NOTED. IT IS NOT KNOWN WHAT THE RESISTANCE WAS WITH, AND THE 2.25X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) BENT AND KINKED. WHEN IT WAS ATTEMPTED TO STRAIGHTEN THE BDC, THE DEVICE SEPARATED PROXIMALLY, OUTSIDE THE ANATOMY. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537821 ↗
• MalfunctionDec 15, 2017Material Rupture

  IT WAS REPORTED THAT AFTER A NON-ABBOTT STENT WAS DEPLOYED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY, THE 2.25 X 8 MM NC TREK BALLOON CATHETER WAS USED FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION. THE DEVICE WAS REMOVED AND A DIFFERENT NON-ABBOTT NON-COMPLIANT BALLOON WAS USED WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122361 ↗