AlphaVac 25-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787253010), received between Aug 19, 2022 and Feb 11, 2025 — classified as 4 deaths.

The most frequently reported specific device problem is “Difficult to Advance” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SCIENTIFIC AND CLINICAL AFFAIRS MANAGER REPORTED A PATIENT EXPIRATION, OCCURING AFTER USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F / C180. THE FOLLOWING WAS REPORTED: "PATIENT SCHEDULED FOR ALPHAVAC PROCEDURE FOR RA THROMBUS AND PE. PRECASE PLAN INCLUDED USING F22180 FOR THE RA THROMBUS AND THEN EXCHANGING FOR F1885 IF CHOOSING TO PROCEED WITH THE PE PORTION. AT PROCEDURE START PATIENT WAS SEDATED AND INTUBATED BY ANESTHESIA WITH VITALS NOTED TO BE HR 120S, NIBP 120S/70S. O2 SATS 97%. ACCESS WAS RFV WITH 26FR. GORE SHEATH WITH NO APPRECIABLE ISSUES. F22180 DEVICE WAS INTRODUCED INTO THE RA OVER THE AMPLATZ SS WIRE AND ASPIRATION WAS ATTEMPTED WITH TEE GUIDANCE. SOME MATERIAL WAS ENGAGED AND REMOVED WITH THE DEVICE. SOME MATERIAL WAS THEN ENGAGED AND NOT ABLE TO BE REMOVED DUE TO THE SIZE AND DENSITY OF THE MATERIAL. WE ATTEMPTED TO REMOVE THE MATERIAL WITH NEGATIVE PRESSURE LOCK ON THE DEVICE THROUGH THE GORE SHEATH. THE MATERIAL WAS REMOVED FROM THE HEART BUT BECAME TRAPPED IN THE LOWER PART OF THE IVC. THE ALPHAVAC DEVICE WAS THEN REMOVED AND NOT RE-INSERTED FOR THE REMAINDER OF THE PROCEDURE. TEE SHOWED NO MATERIAL IN THE RA AND LIVE TEE WAS MAINTAI

  Patient problems: Pulmonary Embolism

  MAUDE report 21356046 ↗
• DeathFeb 10, 2025Difficult to Advance; Difficult to Advance

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING AN OFF-LABEL ALPHAVAC PROCEDURE. IT WAS REPORTED THAT THE MASS THAT WAS BEING REMOVED HAD EMBOLIZED TO THE LUNG, RESULTING IN THE PATIENT'S EXPIRATION. THE FOLLOWING WAS REPORTED FROM THE TECH WHO WAS SCRUBBED IN FOR THE PROCEDURE: "THE PATIENT WAS A 26 YEAR OLD MALE WITH ADVANCED METASTATIC CANCER AND HE HAD A TUMOR THAT WAS BLOCKING HIS IVC/RA. HE WAS TERMINAL BUT THIS TUMOR WAS CAUSING RENAL AND LIVER FAILURE AND THEY WANTED TO IMPROVE HIS QUALITY OF LIFE BEFORE HE DIED. DR. (B)(6) STARTED OUT BY TRYING TO SNARE THE TUMOR PIECE BY PIECE WITH AN ENSNARE AND THE ONO DEVICE. EARLY IN THE PROCEDURE WE SAW ON THE ECHO HOW HE HAD PULLED OFF A BIG PIECE, BUT IT FELL OUT OF THE SNARE AND WE DIDN'T KNOW WHERE I WENT . (B)(6) WENT ON AND WAS TAKING PIECES OF THE TUMOR OUT. HE SWITCHED FROM THE SNARE TO THE ALPHAVAC AT SOME POINT (22FR) AND IT WORKED OKAY. WE HAD AN ISSUE WITH IT AT ONE POINT (B)(4) BUT I CAN'T REMEMBER WHAT HAPPENED WITH IT WHICH IS WHY WE OPENED ANOTHER ONE. THE PATIENT STARTED CODING AT ONE POINT AND WE OPENED THE 18FR VERSION (B)(4). THE DILATOR WOULDN'T PASS THROUGH THE WHOLE DEVICE AS MU

  Patient problems: Pulmonary Embolism

  MAUDE report 21344525 ↗
• DeathFeb 9, 2025Difficult to Advance; Difficult to Advance

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING AN OFF-LABEL ALPHAVAC PROCEDURE. IT WAS REPORTED THAT THE MASS THAT WAS BEING REMOVED HAD EMBOLIZED TO THE LUNG, RESULTING IN THE PATIENT'S EXPIRATION. THE FOLLOWING WAS REPORTED FROM THE TECH WHO WAS SCRUBBED IN FOR THE PROCEDURE: "THE PATIENT WAS A 26-YEAR-OLD MALE WITH ADVANCED METASTATIC CANCER AND HE HAD A TUMOR THAT WAS BLOCKING HIS IVC/RA. HE WAS TERMINAL BUT THIS TUMOR WAS CAUSING RENAL AND LIVER FAILURE AND THEY WANTED TO IMPROVE HIS QUALITY OF LIFE BEFORE HE DIED. DR. (B)(6) STARTED OUT BY TRYING TO SNARE THE TUMOR PIECE BY PIECE WITH AN ENSNARE AND THE ONO DEVICE. EARLY IN THE PROCEDURE WE SAW ON THE ECHO HOW HE HAD PULLED OFF A BIG PIECE, BUT IT FELL OUT OF THE SNARE AND WE DIDN'T KNOW WHERE I WENT. (B)(6) WENT ON AND WAS TAKING PIECES OF THE TUMOR OUT. HE SWITCHED FROM THE SNARE TO THE ALPHAVAC AT SOME POINT (22FR) AND IT WORKED OKAY. WE HAD AN ISSUE WITH IT AT ONE POINT (B)(4) BUT I CAN'T REMEMBER WHAT HAPPENED WITH IT WHICH IS WHY WE OPENED ANOTHER ONE. THE PATIENT STARTED CODING AT ONE POINT AND WE OPENED THE 18FR VERSION (B)(4). THE DILATOR WOULDN'T PASS THROUGH THE WHOLE DEVICE AS MUC

  Patient problems: Pulmonary Embolism

  MAUDE report 21341038 ↗
• DeathAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, AN ALPHAVAC CASE TOOK PLACE AT (B)(6) HOSPITAL FOR THE REMOVAL OF MATERIAL FROM PATIENT'S TRICUSPID VALVE (TCV) AND RIGHT VENTRICLE (RV). THE PATIENT WAS PREPPED AND SEDATED ACCORDING TO PROTOCOL. A 260CM ROSEN WIRE WAS INSERTED AND A 6FR PIGTAIL CATHETER WAS INSERTED OVER THE WIRE INTO THE IVC. A VENOGRAM CONFIRMED THE IVC WAS CLEAR. THE PIGTAIL CATHETER WAS REMOVED, AND AFTER SERIAL DILATION, A 26FR GORE DRY SEAL SHEATH WAS INSERTED OVER AN AMPLATZ SUPERSTIFF WIRE. THE DILATOR WAS REMOVED AND THE AMPLATZ WIRE REMAINED IN PLACE FOR THE INSERTION OF THE ALPHAVAC CANNULA AND SHEATH. THE ALPHAVAC WAS OPENED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE ALPHAVAC CANNULA WAS INSERTED INTO THE GORE DRY SEAL AND ADVANCED TO THE IVC/RA JUNCTION. THE WIRE AND OBTURATOR WERE REMOVED, AND THE CANNULA WAS ATTACHED TO THE ALPHAVAC HANDLE AND INSERTED THROUGH THE GORE DRY SEAL SHEATH IN ACCORDANCE WITH THE IFU. THE ALPHAVAC WAS ADVANCED INTO THE RA, AND A FINAL DEVICE PREPARATION WAS PERFORMED PER THE IFU. ONCE THE CANNULA WAS NEAR THE MATERIAL ON THE TRICUSPID VALVE, THE PHYSICIAN TIMED THREE 10ML PULLS WITH THE CLOSURE OF THE TCV. ONCE ENGAGED WITH THE MATERIAL ON THE TC

  Patient problems: Diminished Pulse Pressure; Pulmonary Embolism

  MAUDE report 15257348 ↗