NC TREK NEO™ 1400375-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648232664), received between Jun 20, 2023 and Jul 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• MalfunctionJul 9, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT CORONARY ARTERY. THE 3.75X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE IMPLANTED STENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). 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 22457135 ↗
• MalfunctionJul 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). A 3.75X8MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER DURING THE INITIAL INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE THE BDC WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO CONTINUED 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 22421373 ↗
• MalfunctionNov 27, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.75X8 MM NC TREK NEO BALLOON DILATATION CATHETER WAS USED FOR PRE-DILATATION, BUT THE BALLOON RUPTURED DURING THE SECOND INFLATION TO 8 ATMOSPHERES. THERE WAS RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY. ANOTHER NC TREK NEO BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799215 ↗
• MalfunctionNov 12, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 100% STENOSED. AFTER AN UNSPECIFIED STENT WAS DEPLOYED A 3.75 X 8 MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION SITE; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY WHEN ADVANCING. THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A 3.75 X 8 MM NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 20664463 ↗
• MalfunctionJun 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% RE-STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.75X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO TARGET LESION AND THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES (ATM) AND THEN TO 18 ATM. HOWEVER, THE BALLOON RUPTURED; THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505124 ↗
• MalfunctionJun 20, 2023Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE LESION WAS ATTEMPTED TO BE PRE-DILATED WITH A NON-ABBOTT MANUFACTURED BALLOON, BUT WAS UNSUCCESSFUL SO THE 3.75X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON WAS PREPPED [AIR ASPIRATED] INSIDE THE ANATOMY. THE BALLOON WAS INFLATED BUT BEFORE REACHING NOMINAL PRESSURE, THE PRESSURE DROPPED INDICATING A RUPTURE. THE BDC WAS REMOVED A RUPTURE IN THE MIDDLE OF THE BALLOON WAS CONFIRMED. A NON-ABBOTT MANUFACTURED BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 17167677 ↗