TREK™ 1012279-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648138768), received between Oct 1, 2018 and Mar 7, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 4.5X15MM TREK BALLOON DILATATION MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY AND RUPTURED AT 10 ATMOSPHERES DURING INFLATION. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS 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 21547678 ↗
• MalfunctionJun 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN TRUNK WITH 90% STENOSIS, NO CALCIFICATION OR TORTUOSITY. A NON-ABBOTT STENT WAS DEPLOYED AND THEN THE 4.5X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. THE BALLOON RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455261 ↗
• InjuryApr 11, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH CALCIFICATION. A POWERTURN GUIDE WIRE WAS ADVANCED TO THE LESION AND A 4.5X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE 4.5X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED ONCE TO NOMINAL PRESSURE FOR POST DILATATION OF THE PROXIMAL RCA; HOWEVER THE BALLOON DID NOT DEFLATE. THE BALLOON WAS SLOWLY REMOVED AND IT WAS ABLE BE REMOVED OUT OF THE AORTA STILL INFLATED. DUE TO THE BALLOON BEING INFLATED, ALL DEVICES WERE REMOVED TOGETHER AS A UNIT, AND THE SHAFT OF THE BALLOON SEPARATED. THE LAST THIRD OF THE DEVICE WAS REMOVED WITH THE INTRODUCER SHEATH. A LONGER COMPRESSION WAS REQUIRED AS WELL AS IMPLANTATION OF A TR BAND FOR CLOSURE DUE TO THE FULLY INFLATED BALLOON AND GUIDING CATHETER BEING REMOVED TOGETHER AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE POWERTURN GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19089785 ↗
• MalfunctionJan 16, 2023Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY THAT IS 50% STENOSED. DURING THE PROCEDURE THE 4.5X15MM TREK BALLOON DILATATION CATHETER RUPTURED AT 20 ATMOSPHERES DURING THE FIRST INFLATION. RESISTANCE WAS FELT WITH ANATOMY DURING REMOVAL OF THE DEVICE. AN UNSPECIFIED CUTTING BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174097 ↗
• InjuryApr 29, 2022Off-Label Use; Difficult to Remove; Material Separation; Difficult to Advance; Off-Label Use; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ILIAC ARTERY THAT WAS HEAVILY CALCIFIED. USING CONTRA-LATERAL APPROACH WITH A LIMA CORONARY GUIDE CATHETER, A 4.5X15MM TREK RX BALLOON DILATION CATHETER WAS ADVANCED TO THE LESION WITH SOME RESISTANCE NOTED. AFTER USE, DURING DEVICE REMOVAL AGAINST RESISTANCE, A PORTION OF THE BALLOON SEPARATED AND REMAINED IN THE LEG. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED BLOCKAGE OF FLOW IN THE ARTERY AND CLAUDICATION IN THE KNEE. ANOTHER STENT WAS ADVANCED AND IMPLANTED TO EMBED THE SEPARATED BALLOON MATERIAL INTO THE ARTERY. ANOTHER 4.5X15MM TREK RX BALLOON DILATION CATHETER WAS ADVANCED TO POST DILATE THE STENT. RESISTANCE WAS NOTED DURING DEVICE REMOVAL AND THE SHAFT SEPARATED OUTSIDE THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 14253437 ↗
• MalfunctionApr 29, 2022Off-Label Use; Difficult to Remove; Material Separation; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ILIAC ARTERY THAT WAS HEAVILY CALCIFIED. USING CONTRA-LATERAL APPROACH WITH A LIMA CORONARY GUIDE CATHETER, A 4.5X15MM TREK RX BALLOON DILATION CATHETER WAS ADVANCED TO THE LESION WITH SOME RESISTANCE NOTED. AFTER USE, DURING DEVICE REMOVAL AGAINST RESISTANCE, A PORTION OF THE BALLOON SEPARATED AND REMAINED IN THE LEG. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED BLOCKAGE OF FLOW IN THE ARTERY AND CLAUDICATION IN THE KNEE. ANOTHER STENT WAS ADVANCED AND IMPLANTED TO EMBED THE SEPARATED BALLOON MATERIAL INTO THE ARTERY. ANOTHER 4.5X15MM TREK RX BALLOON DILATION CATHETER WAS ADVANCED TO POST DILATE THE STENT. RESISTANCE WAS NOTED DURING DEVICE REMOVAL AND THE SHAFT SEPARATED OUTSIDE THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253435 ↗
• InjuryJul 27, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY, NOT THE LEFT MAIN AS INITIALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12229318 ↗
• MalfunctionJun 30, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY THAT WAS 99% STENOSED. THE TREK BALLOON WAS INFLATED AT THE LESION TWO TIMES AT 16 ATMOSPHERES BUT WOULD NOT DEFLATE AFTER THE SECOND INFLATION. THE DEVICE WAS REMOVED WITH THE OTHER DEVICES, WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT LEFT THE CARDIAC CATHETERIZATION LAB IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215099 ↗
• MalfunctionOct 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH NO TORTUOSITY, MILD CALCIFICATION AND 75% STENOSIS. A 4.50 X 15 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH NO RESISTANCE FOR PRE-DILATATION. ON THE INITIAL INFLATION OF THE BALLOON OF THE BDC, THE PRESSURE DECREASED AT 6 ATMOSPHERES AND THE BALLOON WAS THOUGHT TO BE RUPTURED. A NON-ABBOTT BDC WAS SUCCESSFULLY USED TO COMPLETE PRE-DILATATION OF THE LESION. THERE WAS 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 7923701 ↗