NC TREK NEO™ 1400225-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648232343), received between May 21, 2023 and Jun 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OBTUSE MARGINAL ARTERY. THE 2.25X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND DIFFICULTY WAS NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY. A SCORING 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 17159517 ↗
• MalfunctionMay 21, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE BALLOON RUPTURED AT 4 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. A LEAK WAS NOTED ON ANGIOGRAM AND THE PRESSURE DID NOT INCREASE WITH USE OF THE INDEFLATOR. THERE WAS NO RESISTANCE WHEN THE BALLOON WAS REMOVED. A PINHOLE WAS NOTED AT THE DISTAL PART OF THE BALLOON. ANOTHER BALLOON WAS USED TO CONTINUE 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 16971031 ↗