NC TREK NEO™ 1400400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648232718), received between Dec 22, 2022 and May 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER THE 4.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, THE BDC WAS ADVANCED TO THE LESION THROUGH RESISTANCE AND ATTEMPTED TO BE INFLATED; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 16ATMS. THEREFORE, THE BDC WAS REPLACED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957532 ↗
• MalfunctionDec 13, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATED TORTUOSITY AND 90% STENOSIS. PRE-DILATATION WAS PERFORMED WITH THE 4.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), WHICH WAS PREPARED PER INSTRUCTIONS FOR USE. THE NC TREK NEO BDC WAS ADVANCED WITH RESISTANCE FELT FROM THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES WHEN A RUPTURE OCCURRED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CONFIRM THE RUPTURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE AND A 4.0X23MM XIENCE SKYPOINT STENT WAS IMPLANTED. 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 20929875 ↗
• MalfunctionMar 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY AND DURING USE OF A 4.0X12MM NC TREK NEO BALLOON DILATATION CATHETER, THE BALLOON SEPARATED FROM THE DELIVERY SYSTEM. MEDICAL INTERVENTION WAS NOT REPORTED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE BDC WAS BEING PREPARED WHEN THE BALLOON SEPARATED FROM THE CATHETER UPON REMOVAL OF THE PROTECTIVE SHEATH. THE SEPARATED PORTION WAS FOUND ON THE STERILE TABLE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874818 ↗
• MalfunctionOct 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. AFTER A 3.5MM CUTTING BALLOON WAS USED, THE 4.0X12MM NC TREK NEO BALLOON WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES AFTER 5 SECONDS INFLATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. A 3.5X12MM NC TREK NEO 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 17891680 ↗
• MalfunctionJul 22, 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 75% STENOSED LESION IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 4.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED FOR 10 SECONDS; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 15 ATMOSPHERES. THERE WAS ALSO RESISTANCE WITH THE ANATOMY DURING REMOVAL OF THE BDC. PRIOR TO USE, THE CATHETER HAD BEEN SOAKED IN SALINE AND PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. 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 17375433 ↗
• MalfunctionJun 14, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATMS). THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17129537 ↗
• MalfunctionApr 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 4.00X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A NON-ABBOTT CUTTING BALLOON 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 16834124 ↗
• MalfunctionFeb 20, 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 HEAVILY TORTUOUS, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY. THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER FAILED TO CROSS DUE TO ANATOMY. THE BDC WAS NOTED TO HAVE A KINKED SHAFT AND RESISTANCE WAS FELT WITH ANATOMY DURING REMOVAL. A NEW NC TREK WAS USED TO SUCCESSFULLY COMPLETE 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 16406068 ↗
• MalfunctionDec 22, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION. THE 4.0X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED AND WAS INFLATED; HOWEVER, PRESSURE STOPPED GOING UP AT 6 ATMOSPHERES. AFTER DEFLATION THE DEVICE WAS REMOVED FROM THE ANATOMY AND A RUPTURE WAS CONFIRMED. A NEW 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 16033672 ↗