NC TREK NEO™ 1400225-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648232367), received between Jun 1, 2023 and Sep 24, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Rupture; Difficult to Advance

  It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous lesion in the left anterior descending artery with a 2.25x15mm NC TREK NEO RX balloon catheter. Reportedly, resistance was encountered against the lesion when advancing the balloon. Upon initial inflation, the balloon ruptured at 6 atmospheres. The procedure was continued using another balloon. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885884 ↗
• MalfunctionMar 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.25 X 15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WAS ENCOUNTERED AT THE LESION. DURING PRE-DILATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. 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 24576320 ↗
• MalfunctionFeb 24, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2.25X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 10 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 24433875 ↗
• MalfunctionMay 20, 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 RIGHT CORONARY ARTERY (RCA). AFTER A NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, THE BDC WAS ADVANCED TO THE LESION THROUGH RESISTANCE AND ATTEMPTED TO BE INFLATED; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATM. THEREFORE, THE BDC WAS REMOVED AND A NEW NC TREK NEO BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054861 ↗
• MalfunctionDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND USED FOR PRE-DILATATION. THE BDC WAS ADVANCED WITHOUT RESISTANCE BUT RUPTURED DURING THE FIRST INFLATION AT ABOUT 8 ATMOSPHERES (ATMS). THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER DEVICE WAS USED TO CONTINUE 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 18387681 ↗
• MalfunctionSep 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE NC TREK NEO 2.25/15 WAS INFLATED FOR 3 SECONDS BUT RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW, SAME SIZE NC TREK NEO BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. 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 17730353 ↗
• MalfunctionJun 1, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE ANATOMY. THE BALLOON WAS INFLATED ONE TIME TO 10 ATMOSPHERES (ATM) AND THE BALLOON RUPTURED. A 2.25X38MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS THEN ADVANCED BUT COULD NOT CROSS THE ANATOMY AND THE STENT STRUT WAS NOTED AS CRUSHED. THE PROCEDURE WAS ABORTED AT THAT POINT AND NO OTHER DEVICE WAS ATTEMPTED TO BE USED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042470 ↗