TREK™ 1012273-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648138379), received between Jun 13, 2017 and Mar 20, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. FOR PRE-DILATATION, THE 2.75X20MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 21659805 ↗
• InjuryDec 23, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.75X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND THE CONTRAST MIX WAS FIFTY-FIFTY NORMAL SALINE AND CONTRAST. THE BDC WAS BEING USED FOR PRE-DILATATION AND WAS INFLATED ONCE WITH A PRESSURE OF 12 ATMOSPHERES (ATMS), HOWEVER, IT DID NOT FULLY DEFLATE. IT WAS NOTED TO HAVE PROBLEMS WITH WITHDRAWAL FROM THE ANATOMY AND CORONARY FLOW WAS ALMOST COMPLETELY STOPPED BY THE BALLOON DESPITE NEGATIVE PRESSURE ON THE MANOMETER. NEGATIVE PRESSURE WAS HELD FOR 12 SECONDS OR SO AND RETRIED SEVERAL TIMES USING A DISPOSABLE INFLATION DEVICE. THE PHYSICIAN ALSO TRIED TO ASPIRATE USING A REGULAR 20 CC SYRINGE BUT DID NOT WORK. AFTER SEVERAL ATTEMPTS OF WITHDRAWAL, THE PHYSICIAN CUT THE PROXIMAL PART OF THE SHAFT IN ORDER TO USE THE GUIDELINER (6F). HOWEVER, IT WAS IMPOSSIBLE TO PULL THE BALLOON INTO THE GUIDELINER. THE BALLOON WAS SUCCESSFULLY RETRACTED INTO THE GUIDING CATHETER USING DEEP INTUBATION. IT WAS WITHDRAWN PARTIALLY INFLATED. ULTIMATELY, THE PROCEDURE WAS COMPLETED SUCC

  Patient problems: Myocardial Infarction

  MAUDE report 13079144 ↗
• MalfunctionApr 13, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED AND MODERATELY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY. A 2.75X20MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS BEING USED FOR PRE-DILATATION AND DURING ADVANCEMENT RESISTANCE WITH THE ANATOMY WAS FELT. ONCE AT THE LESION SITE, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 12 ATMOSPHERES. THE DILATATION WAS SUFFICIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF AN UNSPECIFIED STENT. 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 9955736 ↗
• MalfunctionJan 13, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A 2.75X20MM RX TREK BALLOON RUPTURED AT 10 ATMOSPHERES ON THE SECOND INFLATION. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE TREK BALLOON CATHETER WAS PREPPED INSIDE THE ANATOMY. 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 9581500 ↗
• MalfunctionAug 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 50% STENOSED AND MODERATELY CALCIFIED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.75X20MM TREK RX BALLOON DILATATION CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE BALLOON RUPTURED DURING FIST INFLATION BETWEEN EIGHT AND TEN ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN BALLOON CATHETER. 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 7795174 ↗
• InjuryJun 13, 2017Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ACUTE MYOCARDIAL INFARCTION PATIENT WHO CAME TO THE EMERGENCY DEPARTMENT IN THE MIDDLE OF THE NIGHT ON (B)(6) 2017. THE PATIENT PREVIOUSLY HAD THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) STENTED ON (B)(6) 2017. WHEN THE PATIENT ARRIVED, THE DIAGONAL WAS SHUTTING DOWN SO THEY DIRECT STENTED WITH AN UNKNOWN XIENCE ALPINE STENT. THEN, THE TREK RX 2.75 X 20 MM BALLOON DILATATION CATHETER WAS USED TO POST-DILATE THE LESION AT 11 ATMOSPHERES, HOWEVER THE BALLOON WOULD ONLY PARTIALLY DEFLATE. THERE WAS DIFFICULTY EXTRACTING THE BALLOON FROM THE ANATOMY AS IT WAS ONLY PARTIALLY DEFLATED AND THIS WAS COMPLETELY BLOCKING FLOW WHICH MADE THE PATIENT EXPERIENCE CHEST PAIN. AN OVER THE WIRE NON-ABBOTT BALLOON WAS LOADED ON THE GUIDE WIRE BACKWARDS IN AN ATTEMPT TO FEED AND POKE/BURST THE TREK RX BALLOON IN AN ATTEMPT TO DEFLATE IT, BUT THIS WAS UNSUCCESSFUL. TREK RX BALLOON WAS ULTIMATELY WITHDRAWN FROM THE ANATOMY PARTIALLY DEFLATED WITH NEGATIVE PRESSURE BEING HELD THE ENTIRE TIME. AFTER THE BALLOON WAS REMOVED FROM THE ANATOMY, THROMBUS WAS NOTED IN THE LAD AND DIAGONAL, WITH THE CIRCUMFLEX PARTIALLY SHUT DOWN. THE PHYSICIAN USED AN A

  Patient problems: Angina; Occlusion; Thrombosis

  MAUDE report 6637251 ↗