NC TREK NEO™ 1400200-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648232312), received between Oct 20, 2023 and May 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE PREVIOUSLY IMPLANTED STENT [ANATOMY]. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES AND RUPTURED. ANOTHER NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334588 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, RETURN DEVICE ANALYSIS FOUND THE BALLOON CATHETER WAS RETURNED WITH BLOOD ON AND IN THE BALLOON FOLDS. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR DESCENDING ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292148 ↗
• MalfunctionAug 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MID-LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WITH 90% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. A 2.00 X 15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED AND PREPPED WITHOUT ANY ISSUES. AFTER SUCCESSFUL GUIDE WIRE CROSSING, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER UNSPECIFIED DEVICE 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 22732998 ↗
• MalfunctionJun 18, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 2.00X15MM NC TREK NEO BALLOON DILATATION CATHETER, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE NC TREK NEO BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. THE NC TREK NEO BDC WAS REMOVED AND AN UNSPECIFIED NC TREK 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 22288304 ↗
• MalfunctionJun 5, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 2.00X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE NC TREK NEO BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE NC TREK NEO BALLOON WAS REMOVED AND A NON-ABBOTT 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 22154995 ↗
• MalfunctionJul 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE 2 X15 NC TREK NEO WAS TO BE USED IN THE MID RIGHT CORONARY ARTERY WITH SEVERE CALCIFICATION. HOWEVER, THE BALLOON RUPTURED AT NOMINAL (12 ATMOSPHERES (ATM)) DURING THE FIRST INFLATION DUE TO THE SEVERELY CALCIFIED ARTERY. THE DEVICE WAS REMOVED AND NUMEROUS UNKNOWN BALLOONS AND A SHOCKWAVE BALLOON WERE 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 19670923 ↗
• MalfunctionMay 1, 2024Material 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 POSTERIOR DESCENDING ARTERY (PDA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 2X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED TO 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED IN 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 19223611 ↗
• MalfunctionJan 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). A 1.50X12MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO PRE-DILATE, HOWEVER, DURING THE FIRST INFLATION A RUPTURE OCCURRED AT 6 ATMOSPHERE FOR 5 SECONDS. A 2.0X15MM NEO TREK BALLOON DILATATION CATHETER (BDC) WAS USED AS A REPLACEMENT. HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 8 ATMOSPHERE FOR 5 SECONDS. THEREFORE, A ROTATIONAL ATHERECTOMY DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619754 ↗
• MalfunctionJan 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. RESISTANCE WAS MET DURING ADVANCEMENT OF THE 2.0X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) TO THE TARGET LESION. THE BALLOON WAS INFLATED TO 6 ATMOSPHERES, BUT RUPTURED AFTER 3 SECONDS. THE BDC WAS REMOVED WITHOUT RESISTANCE AND ANOTHER SAME SIZE NC TREK NEO 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 18476640 ↗
• MalfunctionOct 20, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. DURING INFLATION OF THE 2.0X15MM NC TREK NEO BALLOON, A RUPTURE WAS NOTED DUE TO CONTRAST LEAKAGE AT 6 ATMOSPHERES. THERE WAS RESISTANCE WITH THE LESION DURING ADVANCEMENT OF THE NC TREK NEO, BUT NO RESISTANCE DURING REMOVAL. A NEW TREK WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS RESISTANCE WITH THE LESION DURING ADVANCEMENT AND NO RESISTANCE DURING REMOVAL. THERE WERE NO REPORTED 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 17980717 ↗