AlphaVac H787253020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15051684025966), received between Dec 6, 2022 and Jan 23, 2026 — classified as 2 deaths, 3 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathJan 23, 2026Fluid/Blood Leak

  AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED A PATIENT DEATH OCCURRED AFTER USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. AT THE BEGINNING OF THE CASE, THE ONE-WAY VALVE ON THE HANDLE WAS LEAKING BLOOD. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME, AND THE PROCEDURE WAS CONTINUED. AT THE END OF THE CASE THE PATIENT CODED AND SUBSEQUENTLY EXPIRED DUE TO A LARGE BILATERAL BLOOD CLOT. THE PHYSICIAN SURMISED THAT A PORTION OF THE CLOT MAY HAVE BROKEN WHEN IT WAS BEING REMOVED, CAUSING SOME SORT OF EVENT BUT HE COULD NOT CONFIRM. THE PHYSICIAN DID STATE TO THE TM THAT THE ANGIODYNAMICS DEVICE WAS NOT TO BLAME FOR THE POOR PATIENT OUTCOME.

  Patient problems: Pulmonary Embolism

  MAUDE report 24162774 ↗
• DeathMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED THAT A PATIENT, WITH SEVERAL COMORBIDITIES, EXPIRED DURING A PULMONARY EMBOLISM (PE) REMOVAL PROCEDURE, AFTER USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE PROCEDURE WAS PERFORMD IN ACCORDANCE WITH THE DEVICE'S IFU AND ALL APPEARED NORMAL ACCORDING TO THE PHYSICIANS; HOWEVER, THE ALPHAVAC WAS REMOVED TO INSPECT IF THE CANNULA OR SHEATH WERE OBSTRUCTED; NEITHER WERE, SO THE GORE DRYSEAL WAS REMOVED. AFTER REMOVAL OF THE DRYSEAL, THE PATIENT'S PRESSURES BEGAN TO DROP AND THEY DECOMPENSATED [CARDIAC ISSUE]. AT THIS TIME, AN ACLS PROTOCOL WAS ACTIVATED. THE PHYSICIANS CHECKED THE PATIENT FOR A PLEURAL EFFUSION, PERICARDIAL EFFUSION AND HEMATOMA; HOWEVER, NONE WERE FOUND. AFTER SEVERAL RESUSCITATION ATTEMPTS, THE PATIENT ULTIMATELY EXPIRED. THIS PROCEDURE WAS THE FIRST ALPHAVAC PROCEDURE FOR BOTH ATTENDING PHYSICIANS; HOWEVER, ONE OF THE ATTENDINGS IS A REGULAR ANGIOVAC USER. THE PHYSICIANS DO NOT BELIEVE THAT ANY ANGIODYNAMICS DEVICE CONTRIBUTED, IN ANY WAY, TO THE PATIENT'S EXPIRATION.

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 22080369 ↗
• InjuryMay 22, 2025Use of Device Problem; Use of Device Problem

  A DISTRIBUTOR REPORTED A PATIENT ADVERSE EVENT OCCURRED DURING TREATMENT USING AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85 CE. IT WAS REPORTED THAT A PERFORATION OF THE PATIENT'S RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OCCURRED DUE TO THE PHYSICIAN MISJUDGING THE PLACEMENT OF THE PULMONARY VALVE AND MISHANDLING THE DEVICE. THE PHYSICIAN IS TRAINED ON THE ALPHAVAC DEVICE AND HAS PARTICIPATED IN 4 PRIOR PROCEDURES. AS A RESULT OF THE RVOT PERFORATION, THE PATIENT REQUIRED CPR AND SURGICAL CLOSURE OF THE LESION AND AN EMBOLECTOMY. CURRENTLY THE PATIENT SHOWS SIGNS OF STROKE AND HAS NOT REGAINED CONSCIOUSNESS; HOWEVER, THE PATIENT'S NEUROLOGISTS BELIEVE THAT HE WILL EVENTUALLY WAKE UP. THE CENTRAL NERVOUS SYSTEM FINDINGS ARE ATTRIBUTED TO THE PATIENT'S GENERAL ARTERIOSCLEROTIC CONDITION AND A BRIEF PERIOD OF HYPO-PERFUSION. THE PATIENT IS CURRENTLY INTUBATED IN THE ICU AND IS SHOWING SIGNS OF RECOVERY BUT WILL REQUIRE LENGTHY REHABILITATION. NO FURTHER DETAILS COULD BE OBTAINED.

  Patient problems: Cardiac Arrest; Embolism/Embolus; Loss of consciousness; Perforation of Vessels; Stroke/CVA

  MAUDE report 22075217 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT DURING A PROCEDURE IN WHICH AN ANGIODYNAMICS DEVICE WAS BEING USED. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE. PHYSICIAN GAINED ACCESS IN R FV, SWAN-GANZ INTRODUCED AND NAVIGATED INTO PA, EXCHANGED FOR LUNDERQUIST WIRE. USE OF SEQUENTIAL DILATORS INTRODUCED AT ACCESS SITE TO ACCOMMODATE 24F GORE DRY SEAL. ALPHAVAC SYSTEM WAS PREPPED WITHIN IFU GUIDANCE AND INTRODUCED THROUGH 24F SHEATH OVER WIRE. AV OUTER SLEEVE WITH DILATOR WAS NAVIGATED OVER WIRE INTO PA. DILATOR AND WIRE EXCHANGED FOR ALPHAVAC CANNULA AND HANDLE SYSTEM. NOTICED LOCKING COMPONENT ON HUB OF ALPHAVAC SHEATH HAD ABNORMAL RESISTANCE UPON INTRODUCTION OF CANNULA. EXPOSED CANNULA INTO RPA, ASPIRATED ON 10CC OPTION AND FLIPPING TO 30CC OPTION. UNDESIRABLE MATERIAL WAS ASPIRATED ALONG WITH 100CC OF BLOOD PHYSICIAN USED ACCESSORY PORT TO INTRODUCE WIRE FOR NAVIGATION INTO LOWER RPA. WIRE WAS TAKEN OUT AFTER GAINING DESIRED POSITION AND ASPIRATED ON 30CC. AN ADDITIONAL 50CC OF BLOOD AND MATERIAL ASPIRATED. INTRODUCED MULTIUSE DIAGNOSTIC CATHETER THROUGH ACCESSORY PORT, DID NOT ACHIEVE DESIRED POSITION. TOOK C

  Patient problems: Decreased Respiratory Rate; Hemorrhage/Blood Loss/Bleeding; Non specific EKG/ECG Changes

  MAUDE report 15931388 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT DURING A PROCEDURE IN WHICH AN ANGIODYNAMICS DEVICE WAS BEING USED. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE. PHYSICIAN GAINED ACCESS IN R FV, SWAN-GANZ INTRODUCED AND NAVIGATED INTO PA, EXCHANGED FOR LUNDERQUIST WIRE. USE OF SEQUENTIAL DILATORS INTRODUCED AT ACCESS SITE TO ACCOMMODATE 24F GORE DRY SEAL. ALPHAVAC SYSTEM WAS PREPPED WITHIN IFU GUIDANCE AND INTRODUCED THROUGH 24F SHEATH OVER WIRE. AV OUTER SLEEVE WITH DILATOR WAS NAVIGATED OVER WIRE INTO PA. DILATOR AND WIRE EXCHANGED FOR ALPHAVAC CANNULA AND HANDLE SYSTEM. NOTICED LOCKING COMPONENT ON HUB OF ALPHAVAC SHEATH HAD ABNORMAL RESISTANCE UPON INTRODUCTION OF CANNULA. EXPOSED CANNULA INTO RPA, ASPIRATED ON 10CC OPTION AND FLIPPING TO 30CC OPTION. UNDESIRABLE MATERIAL WAS ASPIRATED ALONG WITH 100CC OF BLOOD. PHYSICIAN USED ACCESSORY PORT TO INTRODUCE WIRE FOR NAVIGATION INTO LOWER RPA. WIRE WAS TAKEN OUT AFTER GAINING DESIRED POSITION AND ASPIRATED ON 30CC. AN ADDITIONAL 50CC OF BLOOD AND MATERIAL ASPIRATED. INTRODUCED MULTIUSE DIAGNOSTIC CATHETER THROUGH ACCESSORY PORT, DID NOT ACHIEVE DESIRED POSITION. TOOK

  Patient problems: Decreased Respiratory Rate; Hemorrhage/Blood Loss/Bleeding; Non specific EKG/ECG Changes

  MAUDE report 15923495 ↗