NC TREK NEO™ 1400275-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648232459), received between Dec 15, 2023 and Sep 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  It was reported that the procedure was to treat the left circumflex coronary artery with heavy calcification, moderate tortuosity and 90% stenosis. The 2.75x8 mm NC Trek Neo balloon dilatation catheter (BDC) was inflated 4 times to 12 atmospheres and ruptured. Another device was used to complete the procedure. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935001 ↗
• MalfunctionMar 12, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. FOR POST-DILATATION, THE 2.75X8MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER TREK BDC. THERE WAS NO ADVERSE PATIENT EFFECT, AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY WAS REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587047 ↗
• MalfunctionFeb 12, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOR POST-DILATATION, THE 2.75X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE UNSPECIFIED IMPLANTED STENT. THE BALLOON WAS INFLATED; HOWEVER, THE DURING THE INITIAL INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER NC TREK BALLOON. 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 24322482 ↗
• MalfunctionOct 24, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY WITH 90% STENOSIS. THE 2.75 X 8MM TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE TREK BDC WAS ADVANCED WITH RESISTANCE NOTED. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER TREK BDC. 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 23381252 ↗
• MalfunctionAug 12, 2025Inflation Problem; Improper or Incorrect Procedure or Method; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 2.75X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE OUTSIDE THE PATIENT ANATOMY WITHOUT ISSUE; BUT WAS NOT SOAKED PRIOR TO USE. THE BDC WAS ADVANCED WITH NO RESISTANCE AND INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON WOULD INFLATE. THE DEVICE WAS REMOVED AND ANOTHER NC TREK NEO 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. RETURN DEVICE ANALYSIS NOTED A TEAR IN THE OUTER MEMBER ON THE SIDE OF THE GUIDE WIRE EXIT NOTCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781479 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.75X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE BUT RUPTURED DURING THE FIRST INFLATION AT AROUND 10 ATMOSPHERES (ATMS). ANOTHER NON-ABBOTT BALLOON WAS USED TO COMPLETE 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 22138201 ↗
• MalfunctionNov 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 2.75X8MM NC TREK NEO BALLOON DILATATION MET CATHETER (BDC) MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT; HOWEVER, ONCE AT THE LESION THE BDC WAS INFLATED. AT THE SECOND INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. ANOTHER NC TREK 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 20625399 ↗
• MalfunctionAug 26, 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.75X8MM 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 AT 12 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 20065607 ↗
• MalfunctionAug 5, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN STENT RESTENOSIS (ISR) IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.75X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. THE BDC WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 10 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE 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 19906949 ↗
• MalfunctionMay 8, 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 MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 2.75X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE LESION. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) AT THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON FOLLOWED BY IMPLANTATION OF A XIENCE STENT WAS USED TO COMPLETE 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 19274111 ↗
• MalfunctionDec 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE 2.75 X 8MM NC TREK NEO RX WAS TO BE USED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) LESION. THE DEVICE WAS INFLATED FOR 6 SECONDS, BUT RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE DEVICE WAS REMOVED AND A NC EUPHORA OF THE SAME SIZE 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 18339736 ↗