NC TREK NEO™ 1400250-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648232381), received between Feb 12, 2025 and Jun 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HT TURNTRAC GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION FOLLOWED BY ADVANCEMENT OF A 2.50X06MM NC TREK NEO BALLOON DILATATION CATHETER (BDC). AFTER INFLATING THE BALLOON TO 12 ATMOSPHERES (ATM), UPON ATTEMPTING TO WITHDRAW THE BDC, RESISTANCE WAS MET AND THE DEVICES WERE STUCK TOGETHER. THE GW WAS UNINTENTIONALLY PULLED OUT ALONG WITH THE BDC. AFTER REMOVAL, AN ATTEMPT WAS MADE TO SEPARATE THE BALLOON FROM THE GUIDEWIRE OUTSIDE THE ANATOMY, BUT IT COULD NOT BE DETACHED. A VERSATURN GW WAS USED TO RE-CROSS THE LESION, AND A NEW NC TREK NEO OF THE SAME SIZE WAS OPENED AND USED FOR ADDITIONAL INFLATION. A 2.50X15MM XIENCE STENT WAS THEN DEPLOYED, COMPLETING 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 22131050 ↗
• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 100% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X6MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; 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 REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364121 ↗