AlphaVac 25-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787253000), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 death.

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. How this data works · Data updated Oct 13, 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.

• DeathNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, AN ALPHAVAC CASE TOOK PLACE AT (B)(6) HOSPITAL. SPECIFICALLY, IT RELATED TO AN IVC THROMBECTOMY CASE IN WHICH A PATIENT PRESENTED WITH AN IVC FILTER AND A CAVAL OCCLUSION BELOW THE FILTER (EXTENDED TO BOTH ILIACS AND POPITEALS). IT WAS NOTED THAT THE PATIENT WAS NOT STABLE ENOUGH TO RECEIVE ANGIOVAC, AND INSTEAD THE ALPHAVAC WAS UTILIZED. THE PATIENT WAS ACCESSED AT BOTH POPLITEALS AND FEMORALS, AND ULTIMATELY THE ALPHAVAC WAS PLACED THRU A 26F GORE DRYSEAL INTO THE RIGHT FEMORAL AND ADVANCED ALL THE WAY UP TO JUST BELOW THE IVC FILTER'S LOCATION. AT THIS POINT THE ALPHAVAC WAS NOT PRIMED, BUT WAS PULLED TO ATTEMPT ENGAGEMENT OF THE THROMBUS, SUBSEQUENT TO WHICH THE CANNULA/FUNNEL WERE IMMERSED IN THE CLOT AND THE FUNNEL COLLAPSED (NO BLOOD WAS RUSHING BACK INTO THE SYRINGE BARREL). UNDER SUCTION, THE ALPHAVAC WAS REMOVED, SUCTION WAS RELEASED, AND A SMALL AMOUNT OF BLOOD AND CLOT CAME BACK INTO THE WASTE LINE AND WASTE BAG. THE CLOT WAS STUCK IN THE INLET VALVE AND HAD TO BE REMOVED VIA FLUSHING OF STERILE SALINE ON THE BACK TABLE. THE PHYSICIAN PROCEEDED TO USE A FORGARTY BALLON TO TRY AND PULL BACK CLOT INTO THE GDS, AND ALSO UTILIZED A CLOTTRIEVER DEVICE WITH LI

  Patient problems: Pulmonary Embolism

  MAUDE report 12781008 ↗