TREK™ 1012271-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648138201), received between Sep 4, 2020 and Nov 13, 2025 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS, LEFT CIRCUMFLEX ARTERY (LCX)LESION WITH 90% STENOSIS. A 2.25 X 8MM TREK BDC WAS PREPARED PRIOR TO USE ACCORDING TO THE INSTRUCTIONS FOR USE, WITH NO ISSUES. THE BDC WAS ADVANCED WITH RESISTANCE NOTED WITH THE TARGET LESION FOR PRE-DILATION. HOWEVER, THE BDC RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER TREK 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 23548575 ↗
• MalfunctionFeb 18, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.25X8MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WAS MET WITH THE ANATOMY. THE BDC WAS INFLATED TO 6 ATMOSPHERES BUT RUPTURED DURING THE FIRST INFLATION. 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 21398480 ↗
• MalfunctionDec 8, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE NC TREK BALLOON CROSSED THE LESION; HOWEVER, DURING AN ATTEMPT TO INFLATE THE BALLOON, THE PRESSURE DID NOT INCREASE. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT BALLOON WAS THEN USED FOR DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS IDENTIFIED FLUID COMING FROM A LONGITUDINAL TEAR ON THE OUTER MEMBER AT THE LOCATION OF THE OUTER MEMBER TO HYPOTUBE SEAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10969948 ↗
• MalfunctionSep 4, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25X8MM TREK BALLOON WAS BEING ADVANCED WHEN A FRACTURE WAS NOTED IN THE MIDDLE AND BEGINNING OF THE SHAFT. THE DEVICE WAS REMOVED AND ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT CONFIRMING THAT BY 'CATHETER FRACTURE' IT MEANT THAT THE SHAFT KINKED IN TWO PARTS, AND WAS NOT FRACTURED/BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS NOTED THERE WAS A LEAK AND A TEAR IN THE OUTER MEMBER DISTAL TO THE GUIDE WIRE EXIT NOTCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494450 ↗