NC TREK NEO™ 1400500-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648232794), received between Jul 17, 2023 and Jan 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 5.0X12MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE SECOND INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER BALLOON 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 23973373 ↗
• MalfunctionJan 7, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY. THE 5X12MM NC TREK BALLON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT AND REMOVAL WITH THE GUIDE CATHETER. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER NC TREK BALLOON. 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 21096336 ↗
• MalfunctionDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT MAIN TRUNK. A 5.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION, HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 18 ATMOSPHERES AFTER 30 SECONDS. A NEW 5.0X8MM NC TREK NEO WAS USED TO 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 18346220 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY THAT IS 100% STENOSED. THE 5.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) RUPTURED AT 10 ATMOSPHERES DURING THE SECOND INFLATION. A NON-ABBOTT DEVICE 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 18187091 ↗
• MalfunctionOct 4, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) THAT WAS MODERATELY CALCIFIED, HEAVILY TORTUOUS AND 95% STENOSED. REPORTEDLY, IT THE NC TREK NEO WAS ADVANCED FOR POST-DILATION OF A MALAPPOSED STENT IN MID RCA. THERE WAS DIFFICULTY ADVANCING THE NC TREK NEO DUE TO CALCIFICATION AT THE TORTUOSITY IN THE VESSEL FROM PROXIMAL TO DISTAL RCA. AFTER BALLOON DILATATION, THE PRESSURE DID NOT INCREASE EVEN AFTER INFLATION, AND THE BALLOON WAS REMOVED AND CHECKED. THE BALLOON WAS NOTED TO BE TORN AND LEAKING CONTRAST MIX. 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 17870443 ↗
• MalfunctionJul 17, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 5.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS NOTED DUE TO THE ANATOMY AND THE BDC FAILED TO REACH THE TARGET LESION. THERE WAS ALSO RESISTANCE DURING REMOVAL OF THE BDC. A NON-ABBOTT BALLOON WAS USED 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 17337478 ↗