TREK™ 1012278-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648138690), received between Sep 29, 2021 and Nov 22, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER STENT DEPLOYMENT, THE 4X8MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND AIR WAS NOTED TO BE IN THE INFLATION DEVICE THAT WAS ATTACHED TO THE BDC. THE INFLATION DEVICE WAS DISCONNECTED FROM THE BDC TO REMOVE THE AIR FROM THE INFLATION DEVICE AND THE BDC WAS ADVANCE AND ATTEMPTED TO BE INFLATED A SECOND TIME WHEN CONTRAST WAS NOTED TO SHOOT DOWN THE VESSEL AND THE BALLOON WAS THOUGHT TO HAVE BURST. THE BDC WAS REMOVED AND WAS NOTED TO BE INTACT. THE PATIENT BECAME UNSTABLE AND ARRESTED; THEREFORE, CPR WAS PERFORMED, AND THE PATIENT WAS ABLE TO BE REVIVED. HOWEVER, THE PATIENT HAD BROKEN RIBS, BUT NORMAL LEFT VENTRICULAR FUNCTION. THE PATIENT WAS MONITORED FOR A FEW DAYS PRIOR TO BEING DISCHARGED. POST PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED OUTSIDE THE PATIENT ANATOMY AND SALINE WAS NOTED TO BE LEAKING FROM A HOLE IN THE SHAFT OF THE BDC. THE ACCOUNT REPORTED THAT IT WAS CONCLUDED THAT THE RESPONSE FROM THE PATIENT

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 20760618 ↗
• MalfunctionSep 29, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY (RCA) INTERVENTION A NON-ABBOTT DEVICE FRACTURED IN THE VESSEL AND THE CATHETER TIP COULD NOT BE SNARED. A TREK 4.0X8MM BALLOON DILATATION CATHETER WAS ADVANCED, BUT HAD SOME DIFFICULTY PASSING THE RETAINED CATHETER TIP IN THE RCA. ONCE AT THE DESIRED LOCATION, THE BALLOON WAS INFLATED TO 16 ATMOSPHERES AND THEN TO 14 ATMOSPHERES FOR 12 SECONDS IN THE MID RCA AT THE SITE OF THE BROKEN CATHETER TIP BEFORE THE BALLOON BURST. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550615 ↗