NC TREK NEO™ 1400600-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648232879), received between Jun 24, 2024 and Jun 4, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 6X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. THERE WERE NO ADVERSE PATIENT EFFECTS. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398481 ↗
• MalfunctionAug 11, 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 RIGHT CORONARY ARTERY (RCA). A 6.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE WITH THE ANATOMY. DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATMS, AND THEREFORE THE BDC WAS REPLACED WITH ANOTHER NC TREK BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778603 ↗
• MalfunctionApr 23, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT ON (B)(6) 2025, AN UNSPECIFIED STENT WAS IMPLANTED; HOWEVER, BECAME DETACHED. ON (B)(6) 2025, A 4.0X28MM NON-ABBOTT STENT WAS IMPLANTED IN THE COMMON CORE. A 6.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, THE BALLOON FAILED TO DEFLATE AND WHEN ATTEMPTING TO REMOVE THE BDC THROUGH THE UNSPECIFIED 6F GUIDE CATHETER RESISTANCE WAS FELT. THEREFORE, THE BALLOON AND GUIDE CATHETER WERE REMOVED AS A SINGLE UNIT. WHEN ATTEMPTING TO INSERT THE UNSPECIFIED ANGIOPLASTY GUIDE BACK ON IT NO LONGER WENT THROUGH THE PROBE AND EVERYTHING NEEDED TO CHANGE EVERYTHING. WITH A LOT OF DIFFICULTIES AN UNSPECIFIED GUIDE WAS PLACED THAT PASSED UNDER THE MESH OF THE NON-ABBOTT STENT THAT DID NOT ALLOW TO PERFORM POST DILATATION DUE TO 4X28 NON-ABBOTT STENT THAT WAS IMPLANTED. A DISSECTION AT THE LEVEL OF OSTIUM OF THE COMMON CORE WAS NOTED. PROCEDURE WAS DISCONTINUED WITH AN ACCEPTABLE ANGIOGRAPHY RESULT. THE PATIENT WAS RELEASED; HOWEVER, WENT INTO CARDIAC ARREST A FEW DAYS LATER AND DIED. IN THE PHYSICIAN'S OPINION, THE DISSECTION AND DEATH WERE NOT DUE TO THE NC TREK NEO BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894434 ↗
• MalfunctionJun 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. A 5.0MM XIENCE STENT WAS IMPLANTED. THE 6.0X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED FOR POST DILATATION HOWEVER THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 11 ATMOSPHERES. A NON-ABBOTT BALLOON (PTA BALLOON 014) WAS ADDITIONALLY USED FOR PROXIMAL PART TO COMPLETE 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 19594030 ↗