NC TREK NEO™ 1400250-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648232428), received between Mar 9, 2023 and Jul 3, 2024 — 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 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.

• MalfunctionJul 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE 2.50 X 20MM NC TREK NEO RX WAS TO BE USED IN THE MID LEFT ANTERIOR DESCENDING (MLAD) LESION. HOWEVER, POST DILATATION, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES (ATM). THEREFORE, THE BALLOON WAS REMOVED AND A NON-ABBOTT BALLOON WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19671121 ↗
• MalfunctionFeb 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A LARGE ORDER WAS RECEIVED AND THE BOTTOM FOUR BOXES WERE DAMAGED A 2.5X20MM NC TREK, 2.5X15MM TREK, AND TWO 2.0X15MM MINI TREK BALLOON DILATATION CATHETERS. THE BOXES APPEAR TO BE SMASHED WITH SOME TEARS ON THE BOXES AND STERILITY IS UNKNOWN. THE DEVICES WERE NOT USED IN A PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712244 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DE NOVO OBTUSE MARGINAL THAT IS 90% STENOSED. THE 2.5X20MM NC TREK NEO BALLOON DILATATION CATHETER RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 2.5X15MM NC TREK NEO BALLOON WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961251 ↗
• MalfunctionMar 9, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 75% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN PROTECTIVE SHEATH WAS REMOVED. THE BDC HAD RESISTANCE DURING ADVANCEMENT AND THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES (ATMS). THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER NON-ABBOTT DEVICE WAS USED FOR PRE-DILATATION AND A XIENCE SKYPOINT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 16512433 ↗