NC TREK NEO™ 1400250-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648232398), received between May 4, 2023 and Jan 7, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, AND 90% STENOSED LEFT CIRCUMFLEX. AN NC TREK 2.50X8MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 8ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH ANOTHER NC TREK. 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 23997810 ↗
• MalfunctionSep 10, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 2.5X8MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY. ONCE AT THE TARGET LESION THE BDC WAS ATTEMPTED TO BE INFLATED; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE PROCEDURE WAS CONTINUED USING ANOTHER NC TREK NEO. NO ADVERSE EVENTS OCCURRED TO THE PATIENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022123 ↗
• DeathAug 8, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD). ON (B)(6) 2025, AN UNSPECIFIED STENT WAS IMPLANTED. THEN 2.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE DISTAL END OF THE STENT WITHOUT ISSUE FOR POST DILATATION. THE BALLOON WAS INFLATED ABOVE THE RATED BURST PRESSURE OF 18 THREE TIMES TO 18, 23 AND 25 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITH NO IMAGING PERFORMED. ANOTHER UNSPECIFIED BALLOON WAS ADVANCED FOR POST DILATION FOR THE PROXIMAL END OF THE STENT. THEN IMAGING WAS PERFORMED WHEN A PERFORATION WAS NOTED AT THE DISTAL END OF THE IMPLANTED STENT AND CARDIAC TAMPONADE WAS OBSERVED. THEREFORE, 2 COVERED UNSPECIFIED STENTS WERE PLACED TO TREAT THE PERFORATION, A STERNOTOMY WAS PERFORMED, AN IMPELLA DEVICE WAS PLACED AND PERICARDIOCENTESIS WAS PERFORMED, WHICH RESULTED IN ADDITIONAL HOSPITALIZATION AS THIS WAS INITIALLY AN OUT PATIENT PROCEDURE. ON (B)(6) 2025, THE PATIENT DIED. IN THE PHYSICIANS OPINION, THE AGGRESSIVE INFLATION OF THE NC TREK CAUSED BOTH THE PERFORATION AND TAMPONADE WHICH LED TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 22754749 ↗
• MalfunctionApr 22, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159048 ↗
• MalfunctionNov 1, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. AFTER PRE-DILATATE THE SEGMENT #1 CORONARY ARTERY WITH A 2.50X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), THE BDC FAILED TO CROSS THE LESION AND MET RESISTANCE DURING REMOVAL DUE TO THE ANATOMY; HOWEVER, WAS REMOVED INDEPENDENTLY. A NON-ABBOTT 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 18052100 ↗
• MalfunctionJul 7, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.50X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE THE ANATOMY. THERE WAS RESISTANCE NOTED WITH THE LESION DURING REMOVAL; HOWEVER, WAS REMOVED INDEPENDENTLY. ANOTHER NON-ABBOTT 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 17278806 ↗
• MalfunctionJun 2, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050300 ↗
• MalfunctionMay 4, 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 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. PRIOR TO USE, THE 2.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. RESISTANCE WAS NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED TO THE LESION FOR PRE-DILATATION. THE BALLOON WAS INFLATED TWICE TO 10 ATMOSPHERES (ATM); HOWEVER, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON FOLLOWED BY STENT IMPLANTATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872526 ↗