TREK™ 1012272-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648138270), received between Jun 15, 2020 and Mar 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION. THE 2.5X8MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, DURING THE FIRST INFLATION AT 2 ATMOSPHERES (ATM) THE BALLOON RUPTURED. THE PROCEDURE WAS CONTINUED WITH A 2.5X12MM TREK RX BDC. 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 21656413 ↗
• MalfunctionJul 16, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THE YELLOW SCANNER IS BEING USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19753930 ↗
• MalfunctionSep 20, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.50X8MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED WHEN RESISTANCE WAS MET WITH THE LESION; HOWEVER, WAS INFLATED ONCE FOR 5 SECONDS WHEN A RUPTURE OCCURRED AT 10 ATMOSPHERES. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE AND AN UNSPECIFIED STENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783291 ↗
• MalfunctionJun 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS A LEFT HEART CATHETERIZATION (LHC) VIA A RADIAL APPROACH. THE 2.50X8MM TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED OVER THE GUIDE WIRE WHEN THE SHAFT WAS NOTED SEPARATED IN TWO PIECES; THEREFORE, THE DEVICE WAS REMOVED. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221101 ↗
• MalfunctionJun 15, 2020Material Separation; Material Separation

  SUS VOLUNTARY EVENT REPORT ((B)(4)) RECEIVED WHICH STATES: WHILE TRYING TO REINSERT 2.5 X 8 TREK PTCA BALLOON, THE SHAFT BROKE AND MADE THE DEVICE UNUSABLE. BALLOON WAS NOT IN PATIENT AT THAT TIME BUT ON THE WIRE ONLY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10156105 ↗