NC TREK NEO™ 1400275-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648232473), received between Jan 5, 2023 and Sep 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949067 ↗
• MalfunctionJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (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 22229279 ↗
• MalfunctionApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AFTER THE 2.75MM XIENCE STENT WAS IMPLANTED AT THE TARGET LESION, THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FOURTH INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON 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 21874479 ↗
• MalfunctionApr 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X38MM XIENCE SKYPOINT STENT WAS IMPLANTED AT THE TARGET LESION. THEN, THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. IVUS WAS USED TO CONFIRM NO ADDITIONAL DILATATION WAS NEEDED AND THE PROCEDURE WAS COMPLETED. 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 21859156 ↗
• MalfunctionJan 8, 2025Contamination /Decontamination Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO 2.75X15MM NON-COMPLIANT (NC)TREK NEO BALLOON DILATATION CATHETERS (BDC) WERE NOTED TO BE BROKEN YET NOT SEPARATED IN THE PACKAGING WITH NO DAMAGE NOTED TO THE PACKAGING. THEY WERE NOT USED. ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT A THIRD DEVICE WAS USED AND THERE WAS A TEAR PROXIMAL TO THE GUIDE WIRE EXIT NOTCH AND AN UNKNOWN GREEN FOREIGN MATERIAL ON THE INFLATION LUMEN ADJACENT TO THE NOTED TEAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107347 ↗
• MalfunctionDec 15, 2024Break; Deformation Due to Compressive Stress; Difficult to Advance; Break; Deformation Due to Compressive Stress; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED WITH RESISTANCE AND THE SHAFT BECAME KINKED, IT DID NOT BREAK. ANOTHER ABBOTT BALLOON DILATATION CATHETER WAS USED TO CONTINUE 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 20935512 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED THAT TWO 2.75X15MM NON-COMPLIANT (NC)TREK NEO BALLOON DILATATION CATHETERS (BDC) WERE NOTED TO BE BROKEN YET NOT SEPERATED IN THE PACKAGING WITH NO DAMAGE NOTED TO THE PACKAGING. THEY WERE NOT USED. ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699214 ↗
• MalfunctionNov 15, 2024Break; Break

  RETURNED DEVICE ANALYSIS IDENTIFIED THAT A THIRD DEVICE WAS USED AND THERE WAS A TEAR PROXIMAL TO THE GUIDE WIRE EXIT NOTCH AND AN UNKNOWN GREEN FOREIGN MATERIAL ON THE INFLATION LUMEN ADJACENT TO THE NOTED TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699210 ↗
• MalfunctionNov 7, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 2.75X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE SECOND INFLATION TO 8 ATMOSPHERES. A NEW NC TREK NEO BDC 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 20633762 ↗
• MalfunctionSep 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AFTER 5 SECONDS AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ROTA AND A NEW NC TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287122 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH 99% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED ONCE AT 12 ATMOSPHERES (ATMS) FOR 10 SECONDS BUT RUPTURED. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING REMOVAL. 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 17995894 ↗
• MalfunctionSep 20, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE LESION DURING ADVANCEMENT; HOWEVER, WAS INFLATED ONCE TO 12 ATMOSPHERES WHEN A RUPTURE OCCURRED AND WAS NOTED DUE TO A LEAKAGE OF THE CONTRAST MIX. ANOTHER TREK 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 17785436 ↗
• MalfunctionMay 4, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. A 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED, HOWEVER IT COULD NOT CROSS THE ANATOMY. DURING ATTEMPTS TO CROSS THE ANATOMY, THE TIP BECAME BENT. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE ANATOMY. 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 16872490 ↗
• MalfunctionMar 17, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO PRE-DILATATE; HOWEVER, RESISTANCE WAS MET DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TORTUOSITY. THERE WAS RESISTANCE MET DURING REMOVAL. A 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 16566841 ↗
• MalfunctionJan 5, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 2.75X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT; HOWEVER, ONCE AT THE LESION THE BDC WAS INFLATED TO 12 ATMOSPHERE AND RUPTURED. A NEW NC TREK NEO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16105863 ↗