NC TREK NEO™ 1400350-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648232640), received between Mar 10, 2023 and Nov 24, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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.

• MalfunctionNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE 3.50X20MM NC TREK NEO RX BALLOON DILATATION CATHETER WAS REMOVED FROM ITS DISPENSER COIL, THE PROXIMAL SHAFT WAS SEPARATED INTO TWO PIECES CLOSE TO THE HUB. THERE WAS NO DEVICE USE OR 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 23633622 ↗
• MalfunctionAug 27, 2025Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT MAIN (LM) ARTERIES. AFTER ROTABLATION, THE 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON A HI-TORQUE BMW UNIVERSAL 190CM GUIDE WIRE (GW). THE BDC WAS USED IN THE PROCEDURE; HOWEVER, WHEN ATTEMPTING TO DEFLATE THE BALLOON FOR 2-3 SECONDS, THE BALLOON WOULD NOT FULLY DEFLATE. AN ATTEMPT WAS MADE TO REMOVE THE BDC FROM THE GW; HOWEVER, THE DEVICE COULD NOT BE REMOVED FROM EACH OTHER AND RESISTANCE WAS NOTED BETWEEN THE DEVICES. AFTER, SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO REMOVED THE PARTIALLY DEFLATED BALLOON WITH THE GW AND 7 FR GUIDE CATHETER (GC) AS AS A SINGLE UNIT. THE PROCEDURE WAS CONTINUED WITH ANOTHER NC TREK NEO BDC. 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 22910170 ↗
• MalfunctionAug 7, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT THE 3.5X20 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE DAMAGED UPON UNPACKAGING OF THE DEVICE. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A BREAK IN THE HYPOTUBE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739216 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO PERFORM INTERVENTION OF A SAPHENOUS VEIN GRAFT (SVG) TO RIGHT CORONARY ARTERY (RCA). A PERFORATION OCCURRED DURING USE OF A 3.50X20MM NC TREK NEO BALLOON DILATATION CATHETER. WHICH WAS TREATED WITH BALLOON TAMPONADE AND DEPLOYMENT OF A 3.50X19MM GRAFTMASTER, SEALING THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 21738031 ↗
• MalfunctionJan 8, 2025Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED IN-STENT RESTENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER WAS USED FOR DILATATION AND ADVANCED WITH NO RESISTANCE. THE BALLOON WAS INFLATED ONCE TO JUST ABOVE RATED BURST PRESSURE WHEN A RUPTURE OCCURRED. RESISTANCE WAS NOTED DURING WITHDRAWAL, NO FORCE WAS APPLIED. A NON-ABBOTT NC BALLOON WAS USED TO CONTINUE 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 21101003 ↗
• MalfunctionOct 8, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MILD CALCIFICATION. THE 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT WITH A .014 GUIDE WIRE AND GOT STUCK BREAKING THE TIP INTO TWO PIECES AS FORCE WAS APPLIED DURING REMOVAL. THE SEPARATED TIP WAS REMOVED TOGETHER WITH THE GUIDE WIRE. ANOTHER NC TREK NEO 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 20402686 ↗
• MalfunctionAug 27, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 4X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE AND THE BALLOON WAS INFLATED TO 24 ATMOSPHERES (ATM) THREE TIMES; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED. IN THE SAME PROCEDURE A 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER WAS USED AND THE BALLOON WAS INFLATED TO 20 ATM TWICE, THE SECOND BALLOON ALSO WOULD ONLY PARTIALLY DEFLATE. DIFFERENT DEFLATION SYRINGES WERE USED IN AN ATTEMPT TO DEFLATE THE BALLOONS. BOTH BALLOONS WERE ULTIMATELY DEFLATED AND WERE REMOVED WITH A HIGH DEGREE OF FRICTION. 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 20078855 ↗
• MalfunctionNov 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). AFTER INFLATION AND DEFLATION OF THE 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS FELT WHEN ATTEMPTING TO REMOVED WITH A NON-ABBOTT GUIDE WIRE. THE BDC WAS ABLE TO REMOVED ON ITS OWN; HOWEVER, WITH STRONG RESISTANCE NOTED. 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 18176711 ↗
• MalfunctionMar 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN THE 3.5X20 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS OPENED AND PREPPED, A PIECE OF PLASTIC WAS NOTED HANGING OFF THE SIDE OF THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE OUTER MEMBER WAS PEELED AND STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525252 ↗