NC TREK NEO™ 1400300-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648232497), received between Feb 1, 2024 and Oct 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• MalfunctionOct 15, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR POST-DILATATION, THE 3X6MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE WITH AN UNSPECIFIED IMPLANTED STENT. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BDC WAS USED TO CONTINUE 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 23292715 ↗
• MalfunctionOct 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY THAT IS 100% STENOSED. THE 1.5X12MM MINI TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE FELT WITH ANATOMY; HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). ADDITIONAL PRE-DILATATION WAS PERFORMED WITH A 1.2X6MM MINI TREK. AFTER A 3.0X12MM TREK BALLOON DILATATION CATHETER WAS USED FOR DILATATION, BUT THE BALLOON RUPTURED DURING FIRST INFLATION AT 6 ATMS. IT WAS NOTED RESISTANCE WAS FELT WITH ANATOMY DURING ADVANCEMENT OF THE 3.0X12MM TREK. A 3.0X6MM NC TREK BALLOON WAS ATTEMPTED TO BE USED, BUT RUPTURED AT THE THIRD INFLATION AT 10 ATMS. ANOTHER UNSPECIFIED BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 20453224 ↗
• MalfunctionJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. A 2.0X15MM BALLOON WAS USED FOR PRE-DILATATION AT 8 ATMOSPHERES AND A 2.75X18MM XIENCE SKYPOINT STENT WAS DEPLOYED. A 3.0X6MM NC TREK NEO BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE USED FOR POST-DILATATION OF THE STENT; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES. THERE WAS 3.0X10MM NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 19762531 ↗
• MalfunctionFeb 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.0X6MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 18624447 ↗