TREK™ 1012278-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648138720), received between Dec 12, 2017 and Feb 9, 2023 — classified as 3 injuries, 1 malfunction.

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

• InjuryFeb 9, 2023Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Off-Label Use; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON FEMORAL ARTERY WITH MILD CALCIFICATION. THE PROTECTIVE SHEATH OF THE 4.00X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS DIFFICULT TO REMOVE, AND THE CONTRAST MIX WAS 60% SALINE, 40% CONTRAST. THE BDC WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE TREK RX BALLOON WAS INFLATED TWICE AT 12 ATMOSPHERES, BUT AFTER THE THIRD INFLATION, THE BALLOON WOULD NOT COMPLETELY DEFLATE. THE MANIFOLD WAS USED TWICE FOR 5 SECONDS, AND NEGATIVE PRESSURE WAS ALSO APPLIED USING A 10CC SYRINGE. THE BALLOON WAS WITHDRAWN HALF INFLATED, AND FORCE WAS APPLIED SINCE RESISTANCE WAS MET WITH THE SHEATH. THE SHAFT BECAME SEPARATED BUT WAS ABLE TO BE REMOVED WITH THE SHEATH. HOWEVER, DUE THE RESISTANCE FROM PULLING BACK, THE GROIN HAD EXTRAVASATION WHICH DID NOT RESOLVE WITH THE BALLOON TAMPONADE, SO A COVERED STENT WAS USED TO TREAT THE BLEEDING. THE PATIENT WAS HOSPITALIZED AND THE NEXT DAY THE PATIENT DEVELOPED AN ACUTE THROMBOSIS IN THE LEFT LEG AND TPA (TISSUE PLASMINOGEN ACTIVATOR) DRIP WAS GIVEN FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 16340133 ↗
• MalfunctionJun 3, 2022Inflation Problem; Leak/Splash; Difficult to Remove; Inflation Problem; Leak/Splash; Difficult to Remove

  IT WAS REPORTED THAT DURING A CORONARY INTERVENTION, THE 4.00 X 20MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION. UPON INFLATION OF THE BALLOON, IT WAS NOTED THAT INFLATION WAS SLOW BEFORE REACHING NOMINAL PRESSURE, SO THE DEVICE WAS ATTEMPTED TO BE REMOVED; HOWEVER, RESISTANCE WAS NOTED WITH THE 0.014 GUIDE WIRE, SO BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. ONCE REMOVED, A LEAK WAS OBSERVED AT THE JUNCTION WITH THE MONORAIL GUIDING CATHETER. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER UNSPECIFIED DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598510 ↗
• InjuryFeb 22, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CAROTID ARTERY WITH NO CALCIFICATION. THE 4.0X20 MM TREK RX BALLOON DILATATION CATHETER (BDC) RUPTURED AT 12 ATMOSPHERES AND RELEASED SOME AIR. THE PATIENT EXPERIENCED STROKE LIKE SYMPTOMS [TRANSIENT ISCHEMIC ATTACK] FOR ABOUT 30 MINUTES AND THEN THEY RESOLVED WITH NO RESIDUAL EFFECTS. NO TREATMENT WAS ADMINISTERED DURING THE 30 MINUTES OF SYMPTOMS. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL BALLOON. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE ADVERSE SYMPTOMS CAUSED BY THE AIR EMBOLISM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Transient Ischemic Attack

  MAUDE report 8363311 ↗
• InjuryDec 12, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT TWO NON-ABBOTT CAROTID STENTS WERE IMPLANTED DURING THE PROCEDURE AND BOTH WERE REMOVED SURGICALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109172 ↗