NC TREK NEO™ 1400400-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648232725), received between Feb 3, 2023 and Jan 23, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING THE FIRST INFLATION AT 6 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER 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 24160615 ↗
• MalfunctionMar 4, 2025Material 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 RIGHT CORONARY ARTERY. THE 4.0 X 15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO INTERACTIONS WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE SECOND 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 21513546 ↗
• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY. THE 4.0X15MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST-DILATATION OF THE IMPLANTED XIENCE STENT; HOWEVER THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 7-8 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 21321273 ↗
• MalfunctionNov 8, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 4.0X15MM NC TREK NEO BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY AND ONCE AT THE LESION THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. 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 20644387 ↗
• MalfunctionSep 23, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), WHICH WAS PREPPED PER INSTRUCTIONS FOR USE, WAS ADVANCED WITH RESISTANCE NOTED FROM THE PATIENT ANATOMY. THE BALLOON WAS INFLATED WHEN A RUPTURE OCCURRED AT AN UNKNOWN PRESSURE. A NON- ABBOTT BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280470 ↗
• InjuryDec 18, 2023Material Rupture; Material Rupture

  THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). FOR PRE-DILATATION, A 4.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, THE BALLOON RUPTURED AT 15 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A DISSECTION WAS NOTED. THEREFORE, A 4.0X33MM XIENCE STENT WAS IMPLANTED WITHOUT ISSUE TO TREAT THE DISSECTION. THEN, A 4.5X12MM NC TREK NEO BDC WAS USED FOR POST DILATATION; HOWEVER, THE BALLOON RUPTURED AT 18 ATM. THE 4.5X12MM NC TREK NEO WAS REMOVED FROM THE PATIENT AND ANOTHER SAME SIZE NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 18348365 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LAD WITH MODERATE CALCIFICATION. AFTER A NON-ABBOTT STENT WAS IMPLANTED, THE 4.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION AND A PROXIMAL DISSECTION WAS NOTED ON OPTICAL COHERENCE TOMOGRAPHY (OCT). THE DISSECTION WAS LEFT UNTREATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 18136018 ↗
• MalfunctionJun 22, 2023Material 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 HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 4.00X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 15 ATMOSPHERES, (ATM). THE BDC WAS REMOVED FROM THE ANATOMY. ANOTHER DEVICE 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 17187309 ↗
• MalfunctionFeb 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY AND THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED AND THEN THE 4.0X15MM NC TREK NEO DILATATION CATHETER BALLOON WAS USED FOR POST-DILATATION. THE BALLOON WAS INFLATED TO AN UNKNOWN PRESSURE AND A RUPTURE OCCURRED. THE DILATATION CATHETER WAS REMOVED WITHOUT DIFFICULTY AND REMAINED INTACT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE POST DILATATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16296773 ↗