TREK™ 1012276-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648138553), received between Feb 8, 2021 and Feb 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN STABLE CONDITION AFTER EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION, BUT PERCUTANEOUS INTERVENTION (PCI) WAS DETERMINED TO BE URGENT. AFTER SUCCESSFUL STENT IMPLANTATION IN THE LEFT CIRCUMFLEX CORONARY ARTERY, A 3.5X8MM TREK BALLOON WAS ADVANCED FOR STENT POST-DILATATION, BUT THE BALLOON FAILED TO INFLATE DURING THE FIRST INFLATION. AT THAT POINT, ELECTROCARDIOGRAM (ECG) CHANGES WERE NOTED, THE PATIENT BECAME SERIOUSLY HYPOTENSIVE AND WENT INTO CARDIAC ARREST. AIR WAS NOTED IN ALL BRANCHES OF THE LEFT CORONARY AND A HOLE WAS NOTED ON THE SHAFT OF THE TREK CATHETER. ADVANCE CARDIOPULMONARY RESUSCITATION WAS INITIATED, INCLUDING INTUBATION, MEDICATIONS AND CARDIAC COMPRESSIONS. AFTER 15 MINUTES, THE PATIENT RECOVERED AND AFTER 2 DAYS, THE PATIENT WAS EXTUBATED, WITH NO ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Cardiac Arrest; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 11298776 ↗