NC TREK NEO™ 1400350-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648232602), received between Nov 1, 2023 and Apr 23, 2026 — 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.

• MalfunctionApr 23, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AND NO ISSUES OCCURRED. THE NC TREK WAS ADVANCED TO THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, TARGET LESION IN THE RIGHT CORONARY ARTERY. RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT. THE NC TREK WAS INFLATED TO 10 ATMOSPHERES AND RUPTURED WITH THIS FIRST INFLATION. AS A RESULT, THE NC TREK WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING ANOTHER NC TREK BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965146 ↗
• MalfunctionSep 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. ONCE AT THE LESION FOR POST-DILATION, A 3.50X6MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. THE NC TREK NEO BDC WAS REMOVED AND A NEW UNSPECIFIED NC TREK 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 23058858 ↗
• MalfunctionMay 16, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. THE 3.50X6MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 22034881 ↗
• MalfunctionDec 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. THE 3.50X6MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 20879160 ↗
• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE NC TREK NEO RX 3.50 X 6MM BALLOON WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 8 ATMOSPHERES. ANOTHER 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 18047985 ↗