TREK™ 1012275-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648138508), received between May 23, 2019 and Feb 1, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED MID RIGHT CORONARY ARTERY THAT IS 75% STENOSED. ONCE A NON-ABBOTT GUIDE WIRE WAS ADVANCED A 3.25X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR PRE-DILATATION; HOWEVER, THE BDC RUPTURED AT 12 ATMOSPHERES DURING THE SECOND INFLATION. ANOTHER NON-ABBOTT DEVICE WAS USED TO PRE-DILATE THE LESION, FOLLOWED BY STENT DEPLOYMENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416446 ↗
• MalfunctionAug 9, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, HEAVILY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. A 3.25X15MM TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE BDC WAS REMOVED BUT RESISTANCE WITH THE ANATOMY WAS FELT. A NON-ABBOTT SMALLER BALLOON CATHETER WAS USED BUT ALSO FAILED TO CROSS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DRUG ELUTING STENT USING AN EXTENSION 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 12294102 ↗
• InjurySep 1, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED SUBSEQUENT TO FILING THE INITIAL REPORT: THE PLACEMENT OF THE GUIDE CATHETER CAUSED THE OCCLUSION AND VENTRICULAR FIBRILLATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion; Ventricular Fibrillation

  MAUDE report 10477867 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.25X15MM TREK RX BALLOON RUPTURED DURING FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365007 ↗
• MalfunctionApr 16, 2020Material Rupture; Material Rupture

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967221 ↗
• MalfunctionMay 23, 2019Material 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 PERFORMED TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, PROXIMAL LEFT ANTERIOR DESCENDING DE NOVO LESION THAT WAS 90% STENOSED. THE 3.25X15MM RX TREK BALLOON DILATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT BUT REACHED THE LESION. THE BALLOON RUPTURED ON THE FIRST INFLATION (AT 18 ATMOSPHERES FOR 15 SECONDS). AN UNSPECIFIED BDC WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 8637381 ↗