NC TREK NEO™ 1400325-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648232572), received between Feb 15, 2023 and Mar 26, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR POST-DILATATION, THE 3.25 X 12 MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BALLOON WAS USED TO CONTINUE 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 24700652 ↗
• MalfunctionDec 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 3.25X12MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER NON-ABBOTT BALLOON WAS USED HOWEVER RUPTURED AS WELL. ATHERECTOMY WAS PERFORMED AND A STENT WAS IMPLANTED 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 23704866 ↗
• MalfunctionNov 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE OSTIAL OBTUSE MARGINAL (OM) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BDC WAS USED TO CONTINUE 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 23490263 ↗
• MalfunctionJul 21, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.25X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 11 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE CONTINUED USING ANOTHER 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 22555485 ↗
• MalfunctionJul 7, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 3.25X12MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BDC WAS USED TO CONTINUE 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 22420176 ↗
• MalfunctionJun 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION THE 3.25X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE WITH THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER NC TREK NEO BDC WAS USED TO CONTINUE 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 22189753 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). AFTER A 3.25X12MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION, THE BDC WAS ATTEMPTED TO BE INFLATED; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE, THE BDC WAS REPLACED WITH A 3.50X12MM NC TREK NEO BDC; HOWEVER, AFTER THE BDC WAS PREPARED AND ADVANCED TO THE LESION, THE BALLOON WAS NOTED TO RUPTURE AT 6 ATMS DURING THE FIRST INFLATION. AT THIS POINT, THE BDC WAS REMOVED AND THE VESSEL WAS PRE-TREATED WITH A ROTATIONAL ATHERECTOMY (ROTA) DEVICE TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994519 ↗
• MalfunctionFeb 4, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE OBTUSE MARGINAL. THE 3.25X12MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 9 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 21304178 ↗
• MalfunctionJul 26, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.25X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. HOWEVER, THAT BALLOON WAS INFLATED AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AS 12 ATMOSPHERES (ATM); THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BALLOON WAS USED TO CONTINUE 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 19843191 ↗
• MalfunctionJul 16, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.50 X 12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE DEVICE WAS REPLACED WITH A 3.25 X 12MM NC TREK NEO BDC. PRE-DILATATION WAS ATTEMPTED USING THE 3.25 X 12MM NC TREK NEO BDC, HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 15 ATMOSPHERES. THE NC TREK NEO BDC WAS REPLACED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED. 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 19748975 ↗
• MalfunctionMay 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR POST DILATATION, THE 3.25X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 18 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 3.5MM NC TREK NEO BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387472 ↗
• MalfunctionMay 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.25X12MM NC TREK NEO BALLOON DILATATION CATHETER RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. ROTABLATION WAS PERFORMED AND A NEW SAME SIZE NC TREK NEO BALLOON 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 19345124 ↗
• MalfunctionDec 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. AN UNSPECIFIED STENT WAS IMPLANTED AND THEN THE 3.25X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE BDC WAS INFLATED ONCE AT 6 ATMOSPHERES (ATM) AND RUPTURED DURING USE. ANOTHER NC TREK 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 18357190 ↗
• MalfunctionDec 7, 2023Difficult 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 A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. REPORTEDLY, THERE WAS RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE 3.25 X 12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) PRIOR TO USE. THE BDC WAS ADVANCED TO THE LESION BUT THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE SECOND INFLATION. EACH INFLATION WAS 20 SECONDS. THE PROCEDURE WAS COMPLETED WITH A NEW NC TREK NEO BDC. 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 18288598 ↗
• MalfunctionNov 14, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVY CALCIFIED, MILDLY TORTUOUS AND 99% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. THE 3.25 X 12MM NC TREK NEO BALLOON DILATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY. ONCE AT THE LESION THE BALLOON OF THE BDC WAS DILATED FOR 5 SECONDS; HOWEVER, RUPTURED AT 10 ATMOSPHERES DURING THE FIRST DILATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 18132655 ↗
• MalfunctionFeb 15, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO USE THE 3.25X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE BDC WAS ADVANCED WITH RESISTANCE NOTED, TO THE TARGET LESION. THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED AT 2 ATMOSPHERES (ATM) DURING THE FIRST INFLATION AFTER 2 SECONDS. THE BDC WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382188 ↗