NC TREK NEO™ 1400275-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648232466), received between Mar 16, 2023 and Sep 30, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 18 most recent of 18 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 50953275 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. USING A 6FR SHEATH AN ORBITAL ATHERECTOMY WAS PERFORMED. AFTER THREE ABLATIONS, A 2.5X10 NON-ABBOTT BALLOON WAS USED FOR DILATION. SUBSEQUENTLY, THE 2.75X12M NC TREK NEO BALLOON DILATATION CATHETER WAS DELIVERED TO THE LESION. ONCE AT THE LESION FOR ADDITIONAL DILATION, THE NC TREK NEO BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. A NEW 2.75X10MM NON-ABBOTT BALLOON WAS USED FOR THE ADDITIONAL DILATATIONS AND A 2.75X15MM XIENCE SKYPOINT DRUG-ELUTING STENT WAS DEPLOYED. A 2.75X10MM NON-ABBOTT BALLOON WAS USED FOR POST-DILATION AND THE PROCEDURE COMPLETE. 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 24832277 ↗
• MalfunctionMar 23, 2026Material Rupture

  IT WAS REPORTED THAT DURING THE INITIAL INFLATION OF THE 2.75X12MM NC TREK NEO BALLOON DILATATION CATHETER, THE BALLOON BURST. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 24664018 ↗
• MalfunctionJan 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. AFTER PLACEMENT OF A STENT, AN NC TREK RX 2.75X12MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT HAD DIFFICULTIES CROSSING THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 8ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES. 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 24111465 ↗
• MalfunctionDec 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 75% STENOSED LEFT ANTERIOR DESCENDING ARTERY. A TREK RX 2.75X12MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 12ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH A NON-ABBOTT DEVICE. 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 23826556 ↗
• MalfunctionOct 15, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE 2.75X12MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE, A NEW TREK BDC WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT AFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296077 ↗
• MalfunctionApr 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE 2.75X12MM RX NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY; HOWEVER WHEN APPLYING NEGATIVE PRESSURE BLOOD WAS OBSERVED RETURNING INTO THE INDEFLATOR. THE DEVICE WAS REMOVED AND ANOTHER ABBOTT DEVICE 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 21805169 ↗
• MalfunctionMar 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.75X12MM NC TREK NEO BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY AND ONCE AT THE LESION RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. ANOTHER NC TREK BALLOON WAS USED TO SUCCESSFULLY 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 21540755 ↗
• MalfunctionFeb 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO MILDLY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. A 2.75X12MM NC TREK NEO CORONARY DILATATION CATHETER RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW NC TREK BALLOON AND ROTABLATOR DEVICE 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 21358693 ↗
• MalfunctionJun 28, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.75X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 19632125 ↗
• MalfunctionMay 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS MID RIGHT CORONARY ARTERY THAT IS 75% STENOSED. AFTER A NON-ABBOTT 2.75MM STENT WAS DEPLOYED THE 2.75X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS INFLATED; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. A NON-ABBOTT 2.75MM BALLOON WAS SUCCESSFULLY INFLATED TO 16 ATMOSPHERES. 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 19346271 ↗
• MalfunctionApr 26, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.75X12MM NC TREK NEO BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY AND RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. A SAME SIZE CUTTING BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193531 ↗
• MalfunctionApr 8, 2024Material Rupture; Material Rupture

  T WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE NC TREK NEO RX 2.75 X 12MM BALLOON WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 19068174 ↗
• MalfunctionMar 12, 2024Material 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 DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. A 6F SHEATH WAS USED. AFTER ABLATION WITH 1.75¿ ROTA, THE 2.75X12¿ NC TREK NEO WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION, DUE TO HEAVY CALCIFICATION. IT WAS NOTED THAT DURING PREPARATION OF THE NC TREK BALLOON, THE DEVICE WAS NOT SOAKED, BUT WAS WIPED WITH A GAUZE SOAKED IN SALINE. DILATION WAS PERFORMED SEVERAL TIMES BY USING NON-ABBOTT 2.75X10¿ BALLOON. A 3.0X18¿ XIENCE SKYPOINT STENT WAS DEPLOYED AND POST-DILATION WAS PERFORMED WITH A 3.0X12¿ NC TREK NEO. 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 18891230 ↗
• MalfunctionFeb 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. A 2.75X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 18810590 ↗
• MalfunctionDec 26, 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 MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. PRE-DILATION WAS PERFORMED WITH 2.75 X12 NC TREK NEO BALLOON DILATION CATHETER (BDC), WHICH WAS PREPARED PER THE INSTRUCTIONS FOR USE. RESISTANCE WAS NOTED WITH THE PATIENT ANATOMY DURING ADVANCEMENT. THE BDC WAS INFLATED UP TO 4 ATMOSPHERES (ATM) WHEN A LEAK OF THE CONTRAST AGENT WAS CONFIRMED WITH IMAGING. LOCATION OF LEAK COULD NOT BE CONFIRMED. UPON REMOVAL OF THE BDC, RESISTANCE WAS FELT WITH PATIENT ANATOMY. ANOTHER NC TREK NEO 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 18393322 ↗
• MalfunctionDec 15, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS THAT WAS HEAVILY CALCIFIED AND MILDLY TORTUOUS AND 90% STENOSED. THE NC TREK NEO RX 2.75 X 12MM WAS ADVANCED WITH RESISTANCE AND INFLATED UP TO 6 ATMOSPHERES BUT RUPTURED DURING THE FIRST INFLATION. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE LESION. ANOTHER TREK AND AN EXTENSION CATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED. 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 18339924 ↗
• MalfunctionMar 16, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY FOR PRE-DILATATION, HOWEVER THE BALLOON RUPTURED ON THE FIRST INFLATION TO 12 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. SUBSEQUENTLY, A 2.75X12MM NC TREK NEO BDC WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY FOR PRE-DILATATION, HOWEVER THIS BALLOON ALSO RUPTURED ON THE FIRST INFLATION TO 12 ATM. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 16560748 ↗