NC TREK NEO™ 1400500-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648232787), received between Apr 4, 2023 and Feb 16, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATE CALCIFICATION, MODERATE TORTUOSITY RIGHT CORONARY ARTERY LESION WITH 90% STENOSIS. A 5.0X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION AT 6 ATM THE BALLOON RUPTURED. A NEW NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24349062 ↗
• MalfunctionFeb 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED LEFT MAIN CORONARY ARTERY AND PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 5.00 X 8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS DUE TO ANATOMY. ONCE AT THE LESION, THE NC TREK NEO BDC RUPTURED AT 18 ATMOSPHERES DURING THE SECOND INFLATION. AN UNSPECIFIED 4.5MM BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315460 ↗
• MalfunctionOct 28, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). FOLLOWING THE DEPLOYMENT OF THE 4.0X12MM XIENCE DRUG-ELUTING STENT, A 5.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR POST-DILATATION; HOWEVER, WAS NOTED TO RUPTURE AT 12ATMS DURING THE THIRD INFLATION. THEREFORE A NEW 4.5X8MM BALLOON CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE XIENCE DELIVERY SYSTEM WAS NOT SOAKED PRIOR TO PREP. THERE WERE NO ADVERSE PATENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407586 ↗
• MalfunctionOct 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 5.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS. THEREFORE, THE BDC WAS REPLACED WITH A NON-ABBOTT BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229545 ↗
• MalfunctionMar 24, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER A 5 X 8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED, WITH NO NOTED ISSUES, IT WAS ADVANCE TO THE LESION THROUGH RESISTANCE AND ATTEMPTED TO BE INFLATED. HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATM. THEREFORE, THE BDC WAS REMOVED AND REPLACED WITH ANOTHER NC TREK BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677668 ↗
• MalfunctionJan 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT IS 100% STENOSED. AFTER DEPLOYMENT OF A 5.0 NON-ABBOTT STENT A 5.0X8MM NC TREK NEO WAS ADVANCED TO PERFORM POST-DILATATION; HOWEVER, DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 12 ATMOSPHERES. ANOTHER 5.0 NC BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 21081448 ↗
• MalfunctionNov 10, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE LEFT MAIN CORONARY ARTERY WITH HEAVY CALCIFICATION. THE 5.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED IN THE PROCEDURE USING THE KISSING BALLOON TECHNIQUE WITH A STENT DELIVERY SYSTEM (SDS); HOWEVER, THE BDC MET WITH RESISTANCE DURING ADVANCEMENT WITH THE BALLOON OF THE SDS AND COULD NOT BE USED. THE BDC ALSO MET RESISTANCE DURING REMOVAL. A NON-ABBOTT BALLOON WAS USED IN 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 18116549 ↗
• MalfunctionOct 10, 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 PROCEDURE WAS TO TREAT AN IN-STENT RE-STENOSIS (ISR) IN THE LEFT MAIN CORONARY ARTERY THAT WAS MODERATELY CALCIFIED. THE 5.0X8MM NC TREK NEO CORONAY DILATATION CATHETER (CDC) WAS PREPPED (AIR ASPIRATION) INSIDE THE ANATOMY PRIOR TO USE. DURING ADVANCEMENT, RESISTANCE WAS MET WITH THE LESION. WHEN THE BALLOON WAS INFLATED TO DILATE THE ISR, THE BALLOON FAILED TO PRESSURIZE FROM AROUND 6 ATMOSPHERES BEFORE THE NOMINAL PRESSURE WAS REACHED. CONTRAST WAS NOTED TO START SPEWING FROM THE BALLOON ON CINE ANGIOGRAPHY. A BALLOON RUPTURE WAS SUSPECTED; THEREFORE THE CDC WAS REMOVED. WHEN IT WAS CHECKED OUTSIDE THE ANATOMY, A RUPTURE WAS CONFIRMED IN THE DISTAL PART OF THE BALLOON. THE ISR WAS DILATED WITH A NON-ABBOTT BALLOON AND DRUG COATED BALLOON 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 17909295 ↗
• MalfunctionAug 15, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE FOR 3 SECONDS WHEN A RUPTURE OCCURRED AT 10 ATMOSPHERES. ANOTHER NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, THERE WAS ALSO A RUPTURE AND THE PROCEDURE WAS DISCONTINUED. THERE WAS RESISTANCE DURING ADVANCEMENT AND REMOVAL DUE THE LESION. 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 17552579 ↗
• MalfunctionJun 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFUMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90%STENOSIS. THE 5.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND DURING THE FIRST INFLATION A RUPTURE OCCURRED AT 12 ATMOSPHERES FOR 10 SECONDS. ANOTHER NON-ABBOTT 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 17120580 ↗
• MalfunctionMay 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). A 5.00X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, TO THE LESION FOR POST-DILATATION. THE BALLOON WAS INFLATED ONE TIME TO APPROXIMATELY 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 16949949 ↗
• MalfunctionApr 21, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 5.00X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO RESISTANCE AND INFLATED TWICE TO 20 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. 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 16791271 ↗
• MalfunctionApr 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING ARTERY THAT WAS MILDLY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED. THE 5.0X8MM NC TREK NEO WAS ADVANCED TO THE LESION AND ON THE FIRST INFLATION, THE BALLOON RUPTURED. THERE WAS NO REPORTED 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 16678396 ↗