TREK 1012405-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648153969), received between Apr 6, 2022 and Oct 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Deflation Problem; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS AN ETHANOL EFFUSION OF THE VEIN OF MARSHALL. THE 2.5X8MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE WITH CONTRAST MIX OF 5ML IODIN AND 15ML SALINE. THE BALLOON WAS INFLATED ONE TIME TO 3 ATMOSPHERES, BUT THERE WAS DIFFICULTY DEFLATING IT. NEGATIVE PRESSURE WAS HELD FOR 5-10 SECONDS; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED. THE BDC WAS REMOVED WITH THE BALLOON PARTIALLY INFLATED. 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 17946482 ↗
• MalfunctionAug 16, 2022Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.5X8 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY AND RUPTURED AT 16 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THERE WAS RESISTANCE NOTED WITH A GUIDING CATHETER DURING REMOVAL. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 15234715 ↗
• MalfunctionApr 6, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.5X8MM TREK RX BALLOON DILATATION CATHETER (BDC) THE SUPPORT STYLET WAS DIFFICULT TO REMOVE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE BDC WAS REPLACED WITH AN UNSPECIFIED DEVICE TO SUCCESSFULLY COMPLETE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022453 ↗