TREK 1012405-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648153976), received between Feb 13, 2018 and Mar 25, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CORONARY ARTERY. THE 2.5 X 12 MM OTW TREK BALLOON RUPTURED DURING FIRST INFLATION AT UNKNOWN ATMOSPHERE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906204 ↗
• MalfunctionFeb 11, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AIR PREP OF A 2.5X12MM TREK OTW THE BALLOON HAD PRESSURE ISSUES. A HOLE WAS WAS OBSERVED ON THE BALLOON. ANOTHER SAME SIZE TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314576 ↗
• MalfunctionNov 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LEFT MAIN AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES. THE TREK BALLOON DILATATION CATHETER WAS ADVANCED AND ATTEMPTED TO INFLATE TWICE TO 4 ATM; HOWEVER, THE DEVICE WOULD NOT HOLD PRESSURE AS THERE WAS A RUPTURE. ANOTHER BALLOON WAS PULLED AND USED TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 10788489 ↗
• MalfunctionApr 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. A 2.50 X12 MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH NO REPORTED RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES. THE BDC WAS SIMPLY REMOVED WITHOUT ISSUE AND A NEW UNSPECIFIED ABBOTT BDC USED TO SUCCESSFULLY CONTINUE 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 8557358 ↗
• MalfunctionJul 12, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE MID CIRCUMFLEX CORONARY ARTERY. RESISTANCE WAS NOTED DURING THE REMOVAL OF THE PROTECTIVE SHEATH FROM A 2.5X12MM TREK OTW BALLOON DILATATION CATHETER (BDC). THE BDC WAS THEN ADVANCED 3-4 INCHES OVER AN UNSPECIFIED LONG GUIDE WIRE AND WOULD NOT ADVANCE ANY FURTHER. THE BDC WAS SIMPLY REMOVED OFF THE GUIDE WIRE WITHOUT RESISTANCE. A NEW, SAME SIZED TREK OTW BDC WAS ADVANCED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681539 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED AND ECCENTRIC LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. A 2.5X12MM TREK OTW BALLOON DILATATION CATHETER WAS BEING USED FOR PRE-DILATATION AT 12 ATMOSPHERES FOR 6 SECONDS; HOWEVER, A DISSECTION OCCURRED. A 2.5X28MM NON-ABBOTT STENT WAS DEPLOYED AT THE PROXIMAL SEGMENT; HOWEVER, THERE WAS CONTINUOUS CONTRAST EXPANSION IN THE ASCENDING AORTA. A 2.8X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 18 ATMOSPHERES AND SUCCESSFULLY SEALED THE DISSECTION AND EXTRAVASATION. THE PATIENT WAS HEMODYNAMICALLY STABLE AND ASYMPTOMATIC. THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO COMPLICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7419381 ↗
• MalfunctionFeb 13, 2018Detachment Of Device Component; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE OF A MILDLY TORTUOUS, MODERATELY CALCIFIED, MID LEFT ANTERIOR DESCENDING ARTERY (LAD), THE 2.5 X 12 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND USED IN THE PROCEDURE WITHOUT ISSUE. NEGATIVE PRESSURE WAS PULLED TWO TIMES FOR BALLOON DEFLATION AS A THICKER CONTRAST SOLUTION RATIO WAS USED. WHILE ATTEMPTING TO REMOVE THE BDC FROM THE ANATOMY, UNSPECIFIED RESISTANCE WAS MET. THE DEVICE WAS PULLED FORCEFULLY AND THE DISTAL SHAFT SEPARATED, BUT REMAINED IN THE GUIDE CATHETER. THE GUIDE CATHETER, GUIDE WIRE AND DEVICE WERE REMOVED AS A SYSTEM FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED AFTER ADDITIONAL PRE-DILATATION AND STENTING OF THE VESSEL WERE PERFORMED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7268798 ↗