NC TREK 1012443-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648151569), received between Jan 19, 2018 and Feb 24, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2019Off-Label Use; Material Separation; Off-Label Use; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT PULMONARY ARTERY. DURING WITHDRAWAL OF A 5.0X20MM NC TREK BALLOON DILATATION CATHETER, THE DISTAL SHAFT BROKE IN TWO PIECES. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION. THE PATIENT IS STABLE AND FINE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364872 ↗
• MalfunctionJan 19, 2018Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT A TARGET LESION IN THE ILIAC ARTERY. THE 5.0 X 20 MM NC TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED. DURING THE FIRST INFLATION, THE NC TREK BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND ALL PORTIONS OF THE BALLOON DILATATION CATHETER WERE REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207971 ↗