NC TREK NEO™ 1400375-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648232671), received between Feb 2, 2023 and Jul 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• MalfunctionJul 15, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 3.75X12MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE NC TREK BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THE NC TREK NEO BDC WAS REMOVED AND AN UNSPECIFIED 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 22511889 ↗
• MalfunctionMar 6, 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 WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.75X12MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, A PINHOLE RUPTURE OCCURRED IN DURING THE FIRST AT 5-6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH A NON-ABBOTT BALLOON 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 21537107 ↗
• MalfunctionMay 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.75X12MM NC TREK NEO WAS BEING USED FOR POST DILATATION; HOWEVER, A RUPTURE OCCURRED AT THE FIRST INFLATION AT 10 ATMOSPHERES. ANOTHER UNSPECIFIED 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 16975190 ↗
• MalfunctionFeb 8, 2023Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE 3.75X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED DURING DEVICE PREPARATION THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 99% STENOSED. THE BDC WAS ADVANCED, AGAINST RESISTANCE, TO THE LESION, BUT DURING THE FIRST INFLATION TO 15 ATMOSPHERES (ATM), THE BALLOON RUPTURED DUE TO THE HEAVY CALCIFICATION. THE BDC WAS REMOVED WITHOUT ISSUE. 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 16329849 ↗
• MalfunctionFeb 2, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (PRCA). A 3.75X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER, IT FAILED TO CROSS THE HIGHLY TORTUOUS SEGMENT OF THE ANATOMY. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 16287967 ↗