NC TREK NEO™ 1400325-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648232565), received between Jul 14, 2023 and Oct 23, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE ACCORDING TO THE INSTRUCTIONS FOR USE AND NO ISSUES OCCURRED. THE NC TREK BDC WAS ADVANCED TO THE TARGET LESION FOR POST-DILATION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY AND RESISTANCE FROM THE ANATOMY WAS NOTED. DURING THE SECOND INFLATION TO 8 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE BDC WAS THEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING ANOTHER NC TREK BALLOON. NO ADVERSE EVENTS OCCURRED TO THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374629 ↗
• MalfunctionJul 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN TRUNK TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. AFTER A NON-ABBOTT 3.0MM STENT WAS DEPLOYED, THE 3.25X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 19818535 ↗
• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A MID RIGHT CORONARY ARTERY THAT IS 75% STENOSED. A 3.0MM STENT WAS DEPLOYED AND 3.25X8MM NC TREK NEO BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE USED FOR POST DILATATION; HOWEVER THE BDC RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER 3.5MM BALLOON WAS USED TO SUCCESSFULLY POST DILATE THE STENT AT 16 ATMOSPHERES. 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 19606978 ↗
• MalfunctionMar 12, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR POST-DILATATION, 3.25X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. 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 18891251 ↗
• MalfunctionJul 14, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH 90% STENOSIS, MILD CALCIFICATION AND MODERATE TORTUOSITY. A GUIDE WIRE CROSSED THE LESION AND A 2.75X13MM BALLOON WAS USED FOR PRE-DILATATION. A XIENCE SKYPOINT STENT WAS DEPLOYED. THE 3.25X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT AND WAS USED TO DILATE THE PROXIMAL END OF THE STENT DEPLOYED, HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATMS). THE CATHETER WAS SOAKED IN SALINE AND THE DEVICE WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. NO RESISTANCE WAS MET WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE UPON REMOVAL OF THE NC TREK NEO BALLOON. ANOTHER 3.25X10MM NON-ABBOTT BALLOON WAS USED FOR POST DILATATION PER STANDARD PROCEDURE AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 17329561 ↗