Merit Medical® 00884450409114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450409114), received between Oct 13, 2022 and Oct 13, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Air/Gas in Device” (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 18, 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.

• InjuryOct 13, 2022Air/Gas in Device; Air/Gas in Device

  THE ACCOUNT ALLEGES THAT A STEMI PATIENT WAS ADMITTED STRAIGHT TO THE INTERVENTIONAL CATH LAB FOR A PERCUTANEOUS CORONARY INTERVENTION [PCI]. A CORONARY ANGIOGRAPHY WAS PREFORMED CONFIRMING A CLOT WITHIN THE WITHIN THE PATIENTS RIGHT CORONARY ARTERY [RCA]. AN EMERGENT THROMBECTOMY AND CORONARY STENT DEPLOYMENT WAS SUCCESSFULLY PREFORMED. WHILE TAKING THE LAST ANGIOGRAM OF THE PATIENT'S CORONARY ARTERY AIR WAS ACCIDENTALLY INTRODUCED INTO THE SYSTEM AND WAS INJECTED INTO THE PATIENT'S RCA. THE PATIENT STARTED TO DISPLAY SYMPTOMS OF A STROKE AND WAS TRANSFERRED TO RADIOLOGY DEPARTMENT FOR COMPUTERIZED TOMOGRAPHY (CT) SCAN AND FURTHER TESTING. THE ACCOUNT ALLEGES THAT THE AIR WAS INTRODUCED SOMEHOW THROUGH THE CONTRAST LINE. THE MANIFOLD DEVICE WAS HARD TO USE. THE EVENT REQUIRED STAFF TO REMEMBER NECESSARY STEPS TO PREVENT AIR FROM ENTERING THE SYSTEM AND REQUIRED TUBING TO BE ALWAYS VERTICAL DURING INJECTION.

  Patient problems: Air Embolism; Ischemia Stroke

  MAUDE report 15599012 ↗