TREK 1012405-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648153990), received between Jan 30, 2018 and Sep 15, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A ROTO BLADE CATHETER WAS ADVANCED AND ROTABLATION WAS PERFORMED ON THE ARTERY. A 2.5X20MM TREK OTW BALLOON DILATATION CATHETER (BDC) WAS BACKLOADED ONTO THE ROTO BLADE WIRE AND INFLATED ONCE TO 8 ATMOSPHERES (ATMS). THE BDC WAS DEFLATED WITHOUT ISSUES AND THE ROTO BLADE WIRE REMOVED. A HI-TORQUE BMW UNIVERSAL GUIDE WIRE WAS ADVANCED THROUGH THE BDC AND THE BDC WAS INFLATED ONCE AGAIN TO 8 ATMS. THE BDC WAS DEFLATED WITHOUT ISSUES; HOWEVER, WHEN ATTEMPTING TO REMOVE THE BDC FROM THE GUIDE WIRE IT WAS STUCK. BOTH THE BDC AND THE GUIDE WIRE HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW BMW AND TREK BDC. 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 15429546 ↗
• MalfunctionJun 3, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. THE 2.5X20MM TREK OTW BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE LOADING ON A HI-TORQUE SPORT WIRE. IT WAS OBSERVED THAT RESISTANCE WAS SIGNIFICANT ONCE THE WIRE GOT 6 INCHES FROM THE END. THE BDC WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). THERE WAS DIFFICULTY PULLING THE BDC OFF OF THE WIRE BUT THE BDC WAS REMOVED INDEPENDENTLY. ANOTHER SAME SIZE TREK OTW BDC WAS USED OVER THE SAME HI-TORQUE SPORT WIRE AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 14594895 ↗
• MalfunctionFeb 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) AND A MID RIGHT CORONARY ARTERY (RCA) LESION. DURING PLACEMENT OF A TREK CORONARY DILATATION CATHETER OVER A NON-ABBOTT GUIDE WIRE, THE TREK DILATATION CATHETER BECAME STUCK WITH THE WIRE. THE CATHETER WAS UNABLE TO BE REMOVED FROM THE WIRE SO ALL WAS REMOVED AS A SINGLE UNIT. THE PATIENT WAS RE-WIRED AND A XIENCE STENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8302635 ↗
• MalfunctionJan 30, 2018Inflation Problem

  IT WAS REPORTED THAT THE 2.5 X 20 MM TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE; HOWEVER, THE BALLOON ONLY PARTIALLY INFLATED. THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ISSUE AND A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228597 ↗