NC TREK NEO™ 1400450-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648232756), received between Mar 30, 2023 and Sep 26, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Material 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 RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. FOR PRE-DILATATION, THE 4.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 23158641 ↗
• MalfunctionFeb 20, 2025Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH FIBROTIC AND LIPID PLAQUE AS SEEN ON OPTICAL COHERENCE TOMOGRAPHY (OCT). A STENT WAS IMPLANTED AND THE 4.5X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. THE BALLOON WAS INFLATED 3 TIMES TO 20 ATMOSPHERES AND NEGATIVE PRESSURE WAS HELD FOR 5-10 SECONDS. AFTER USE, THE BALLOON DID NOT REWRAP CORRECTLY AND IT WAS DIFFICULT TO REMOVE FROM THE GUIDING CATHETER. THE BALLOON WAS DEFLATED BUT NOT RE-WRAPPED. SOME FORCE WAS REQUIRED TO REMOVE THE DEVICES. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428351 ↗
• MalfunctionDec 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE OBTUSE MARGINAL. THE 4.0X12MM 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 6 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 20879233 ↗
• MalfunctionJun 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 4.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) AND THE HT BMW UNIVERSAL II 190CM GUIDE WIRE (GW) WERE USED IN THE PROCEDURE; HOWEVER, THE BDC AND GW BECAME STUCK TOGETHER. THEREFORE, THE BDC AND GW WERE REMOVED AS A SINGLE UNIT AND THE GW WAS NOTED TO HAVE SEPARATED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512140 ↗
• MalfunctionJan 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED AT 18 ATMOSPHERES DURING THE SECOND INFLATION. 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 18460547 ↗
• MalfunctionDec 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348350 ↗
• MalfunctionMar 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). FOR POST DILATATION, THE 4.50X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; 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. A NON-ABBOTT BALLOON WAS USED FOR POST-DILATATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644997 ↗