NC TREK NEO™ 1400200-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648232305), received between Mar 16, 2023 and May 1, 2026 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2X12MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. AT THE TARGET LESION THE BALLOON WAS INFLATED, HOWEVER, DURING THE INITIAL INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, AND ANOTHER TREK BALLOON WAS USED TO CONTINUE 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 25058904 ↗
• MalfunctionMar 9, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED RIGHT CORONARY ARTERY. AN NC TREK 2.00X12MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT HAD DIFFICULTIES CROSSING THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 11ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH ANOTHER NC TREK. 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 24547130 ↗
• MalfunctionMar 9, 2026Material Separation; Deformation Due to Compressive Stress; Packaging Problem

  IT WAS REPORTED THAT WHEN REMOVING THE 2.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) FROM THE PACKAGING, THE COIL DISPENSER WAS NOTED TO BE KINKED. WHEN THE BDC WAS REMOVED FROM THE COIL DISPENSER, THE PROXIMAL SHAFT WAS KINKED AND THEN SEPARATED AT THE KINKED LOCATION. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545301 ↗
• MalfunctionJan 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. PREPARATION PRIOR TO IN-VIVO USE WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND NO ISSUES OCCURRED. THE 2.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE TO THE TARGET LESION FOR PRE-DILATATION AND RUPTURED AT 8 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 24109499 ↗
• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00X12MM NC TREK NEO BALLOON DILATATION CATHETER, RESISTANCE WAS FELT DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE NC TREK NEO BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE INITIAL INFLATION. 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 23548578 ↗
• MalfunctionAug 19, 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 DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER NC TREK BALLOON WAS USED TO CONTINUE 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 22846812 ↗
• MalfunctionJul 14, 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 DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR DILATATION, THE 2X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERE (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE, FOLLOWED BY IMPLANTATION OF A 2.25X28MM XIENCE STENT 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 22494950 ↗
• MalfunctionMar 31, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 2X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE LESION; AND ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS. THEREFORE, THE BDC WAS REMOVED AND REPLACED WITH A NON-ABBOTT BALLOON, AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE 2X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION THROUGH RESISTANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733501 ↗
• MalfunctionFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING PRE-DILATATION A PIN HOLE RUPTURE WAS NOTED AFTER THE BDC WAS INFLATED ONCE TO 6ATM AND DILATATION WAS HELD FOR 10 SEC. THE BDC WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A 3.0X23MM XIENCE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404469 ↗
• MalfunctionJan 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER BALLOON WAS USED TO CONTINUE 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 21072775 ↗
• MalfunctionOct 30, 2024Material Rupture; Material Rupture

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS NOTED THAT THE NC TREK NEO BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND THEN RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569499 ↗
• MalfunctionSep 19, 2024Material 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 DISTAL RIGHT CORONARY ARTERY (DRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS 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 20263132 ↗
• MalfunctionSep 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY. FOR PRE-DILATATION THE 2X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM) DURING THE FIRST INFLATION AFTER 5 SECONDS. THEREFORE THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ROTABLATION, FOLLOWED BY DILATION WITH A 3.5X12MM NC TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214576 ↗
• MalfunctionSep 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. A NON-ABBOTT 3.5MM STENT WAS DEPLOYED IN THE LESION. THE 2.0X12 MM NC TREK NEO BALLOON WAS ATTEMPTED TO BE DILATED INTO FIRST DIAGONAL ARTERY THROUGH THE STENT STRUT, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163323 ↗
• MalfunctionJul 26, 2024Material 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 DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 2X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION 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. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842905 ↗
• MalfunctionDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE 90% STENOSED, MILDLY CALCIFIED AND MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (DRCA). THE BALLOON OF A 2.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS INFLATED FOR 5 SECONDS. DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. A 2.00 X 12MM MINI TREK BDC WAS ADVANCED AND THE BALLOON INFLATED FOR 4 SECONDS TO 5 ATMOSPHERES; HOWEVER, ALSO RUPTURED. LASTLY A 2.0X20MM MINI TREK BDC WAS ADVANCED AND THE BALLOON INFLATED FOR 4 SECONDS, THE BALLOON RUPTURED AT 5 ATMOSPHERES ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A SAPPHIRE BDC WITHOUT REPORTED ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268991 ↗
• MalfunctionNov 30, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 2.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO ANATOMY. THERE WAS ALSO RESISTANCE FELT WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT BALLOON WAS USED TO 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 18241412 ↗
• MalfunctionOct 13, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 99% STENOSED. THE 2.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH ANATOMY AND DURING THE FIRST INFLATION THE BDC RUPTURED AT 10 ATMOSPHERES. ANOTHER TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION DUE TO HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931137 ↗
• MalfunctionMay 30, 2023Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED. REPORTEDLY, THE NC TREK NEO RX 2.00 X 12MM BALLOON DILATATION CATHETER (BDC) RUPTURED AT 20 ATMOSPHERES DURING THE FIRST INFLATION. THE INFLATION TIME WAS FOR 20 SECONDS. REPORTEDLY THERE WAS RESISTANCE ADVANCING AND REMOVING THE BDC. A CUTTING BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026712 ↗
• MalfunctionMar 16, 2023Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING UNPACKAGING THE 2X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), THE TIP FELL OFF. THERE WAS NOT RESISTANCE MET DURING REMOVAL AND NOT DAMAGE NOTED TO THE DISPENSER HOOP OR CHIPBOARD BOX. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, 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 16558336 ↗