NC TREK NEO™ 1400550-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648232831), received between Feb 22, 2023 and Aug 6, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A 5.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, THE BDC WAS ADVANCED TO THE LESION, THROUGH RESISTANCE, AND ATTEMPTED TO BE USED FOR POST-DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS, THEREFORE THE BDC WAS REPLACED WITH ANOTHER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729066 ↗
• MalfunctionSep 23, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 85% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 5.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED 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. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20285946 ↗
• MalfunctionFeb 22, 2023Deflation Problem; Leak/Splash; Material Rupture; Deflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY THAT WAS MODERATELY CALCIFIED, HEAVILY TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 14 ATMOSPHERES (ATM) FOR 5 SECONDS ONCE, WHEN THE PRESSURE WAS NOTED TO DECREASE. THERE WAS SOME DELAY DURING DEFLATION, BUT THE BALLOON HAD HARDLY INFLATED, SO THERE WAS NO ISSUE DURING REMOVAL OF THE BALLOON. ONCE OUTSIDE THE ANATOMY, THE BALLOON WAS TESTED AND FLUID LEAKAGE FROM THE BALLOON WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16424154 ↗