NC TREK 1012451-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648151958), received between Jan 29, 2020 and Jan 17, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 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.

• MalfunctionJan 17, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, CONCENTRIC LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE 3.5X6 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO ADVANCE BUT IT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THE NC TREK BDC WAS REMOVED INDEPENDENTLY WITH RESISTANCE NOTED WITH THE ANATOMY. OTHER DEVICES ALSO DID NOT CROSS THE LESION SO IT WAS ENDED AND ROTA-BLATION WAS SCHEDULED FOR NEXT TIME. 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 13266436 ↗
• MalfunctionSep 28, 2020Leak/Splash; Material Twisted/Bent; Material Split, Cut or Torn; Leak/Splash; Material Twisted/Bent; Material Split, Cut or Torn

  ABBOTT VASCULAR RECEIVED THIS DEVICE WITHOUT A REPORTED COMPLAINT. UPON DEVICE INVESTIGATION, IT WAS NOTED THAT THE BALLOON LEAKED FROM A TEAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596950 ↗
• MalfunctionAug 20, 2020Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED CORONARY ARTERY. THE NC TREK RX BALLOON COULD NOT BE INFLATED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS NOTED A LEAK IN THE BALLOON AND A LONGITUDINAL RUPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433914 ↗
• MalfunctionJan 29, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE 3.5X6 MM NC TREK WAS FLUSHED IN THE HOOP AND WAS PREPARED FOR USE. THE NC TREK WAS LOADED ON TO THE 014 SION BLUE GUIDE WIRE WITHOUT ISSUE. THE NC TREK WAS ADVANCED WITHOUT RESISTANCE UNTIL RIGHT BEFORE THE TUOHY WHEN THE NC TREK WOULD NO LONGER ADVANCE ON THE WIRE. THE NC TREK WAS DIFFICULT TO REMOVE AND FRACTURED IN TWO PIECES DURING REMOVAL FROM THE GUIDE WIRE. ANOTHER NC TREK WAS SUCCESSFULLY ADVANCED ON THE SAME GUIDE WIRE WITHOUT INCIDENT. 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 9644185 ↗