AlphaVacRecalls & reported problems across all models

We found 4 models of AlphaVac by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2021 and Jan 23, 2026 — classified as 19 deaths, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AlphaVac problems

AlphaVac models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AlphaVac 25-302

  Aspiration thrombectomy catheter
  12 deaths17 reports
• AlphaVac H787253020

  Aspiration thrombectomy catheter
  2 deaths5 reports
• AlphaVac 25-301

  Aspiration thrombectomy catheter
  4 deaths4 reports
• AlphaVac 25-300

  Aspiration thrombectomy catheter
  1 death1 report

Recent AlphaVac adverse event reports

The 15 most recent reports across all models, 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 ↗
• DeathOct 16, 2025Material Deformation; Material Deformation

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED RECEIVING NOTIFICATION FROM A PHYSICIAN, THAT THE FOLLOWING EVENT OCCURRED DURING AN ALPHAVAC PULMONARY EMBOLISM PROCEDURE: " I WAS CONTACTED BY (B)(6) TO SEE IF I COULD COVER A PE CASE. IT WAS A 2.5 HOUR DRIVE SO THE HOSPITAL WAS PREPARING TO START THE CASE KNOWING I WOULD ARRIVE AT ROUGHLY 2PM. THE PHYSICIANS, DR. (B)(6), WERE SCRUBBED IN WHEN I ARRIVED. THEY HAD A PIGTAIL CATHETER IN THE PATIENTS PA. THE PATIENT WAS INTUBATED BUT I DID NOT GET ANY ADDITIONAL INFORMATION AS TO WHAT LEAD TO HER INTUBATION OR HOW SHE PRESENTED WITH HER PE. I DID NOT GET HER EXACT DOB BUT THE STAFF SAID SHE WAS IN HER LATE 70'S AND THE PHYSICIAN SAID THAT SHE "HAD MANY MEDICAL PROBLEMS IN ADDITION TO HER PE". THE PHYSICIANS DID NOT HAVE ANY TROUBLE USING ALPHAVAC. THEY WERE ABLE TO DELIVER THE OVER SHEATH AND MANIPULATE THE CANNULA WITHOUT TROUBLE IN THE RIGHT LUNG AND IN THE LEFT LUNG. WHILE IN THE LEFT LUNG DR. (B)(6) NOTICED THE CANNULA WAS KINKED ON THE MOST PROXIMAL END NEAR THE HANDLE FROM HOLDING THE HANDLE AT AN ANGLE THAT CAUSED THE KINK. THEY REMOVED THE CATHETER, DELIVERED A PIGTAIL TO THE MAIN PA AND TOOK AN ANGIO. THEY NOTICED THAT THER

  Patient problems: Pulmonary Embolism

  MAUDE report 23309621 ↗
• 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 ↗
• DeathFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED A PATIENT DEATH OCCURRED, AFTER USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE PATIENT ULTIMATELY EXPIRED AS A RESULT OF A 'MASSIVE PULMONARY EMBOLISM.' THE PHYSICIAN STATED THAT THE PATIENT'S EXPIRATION IS IN NO WAY ASSOCIATED WITH THE ALPHAVAC DEVICE BUT DUE TO PATIENT COMORBIDITIES. THE FOLLOWING WAS REPORTED: "35 YEAR OLD MALE PT,WITH FACTOR 5 DEFICIENCY, NON COMPLIANT WITH MEDICATIONS FOR 6 MONTHS, ADMITTED FOR BILATERAL AND SADDLE PE. PT CONSENTED BY PHYSICIAN, TIME OUT STATED, PT PREPPED AND DRAPED IN STERILE FASHION, RIGHT FEMORAL VENOUS ACCESS WITH 26F GORE DRYSEAL. PT ON HEPARIN GTT AND PHYSICIAN GAVE HEPARIN BOLUS, PHYSICIAN STATES "WE DO NOT NEED TO CHECK ACTS". PT PRE PA PRESSURES WERE 65/18/35 O2 98% HR IN 120'S. PHYSICIAN NAVIGATED ALPHAVAC F1885 TO LUNGS AND BEGAN MECHANICAL ASPIRATION. CLOT REMOVED WAS DARK AND BRIGHT RED IN COLOR, GELATINOUS IN TEXTURE. BLOOD WAS FILTERED AND RETURNED BY PHYSICIAN. PHYSICIAN TOOK POST ANGIOGRAMS, CLOT BURDEN WAS DECREASED. ALPHAVAC DEVICE WAS REMOVED FROM BODY AS PHYSICIAN STATED, "I AM FINISHED REMOVING CLOT AND WILL ALLOW HEPARIN TO WORK." PHYSICIAN ASSESSED DEVICE O

  Patient problems: Pulmonary Embolism

  MAUDE report 21469457 ↗
• 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 MUC

  Patient problems: Pulmonary Embolism

  MAUDE report 21344915 ↗
• 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 MUC

  Patient problems: Pulmonary Embolism

  MAUDE report 21344878 ↗
• 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 ↗
• 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

  Patient problems: Pulmonary Embolism

  MAUDE report 21341037 ↗
• 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

  Patient problems: Pulmonary Embolism

  MAUDE report 21341036 ↗
• DeathJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TERRITORY MANAGER (TM) REPORTED AN ADVERSE EVENT DURING A PROCEDURE USING AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE FOLLOWING WAS REPORTED: " A PATIENT EXPIRED FROM, WHAT IS BELIEVED TO BE, A PERICARDIAL EFFUSION. AFTER REMOVING MATERIAL FROM THE RIGHT SIDE OF THE LUNG AND SWITCHING TO THE LEFT, THE PHYSICIAN LOST ACCESS AND THE CANNULA FELL OUT OF THE LUNGS AND INTO THE RVOT/RV. THE PHYSICIAN TRIED TO REGAIN ENTRY INTO THE MAIN PULMONARY ARTERY BY ADVANCING THE CANNULA. WHEN HE WAS STEERING IN THE HEART, THE FUNNEL DIDN'T HAVE THE FULL BEND OF THE CANNULA PLUS 2 CM. IT WAS BARELY EXPOSED OUT OF THE OUTER SHEATH. THE TM RECOMMENDED THEY REMOVE THE WHOLE SYSTEM AND START OVER WITH THE SWAN OR SOME OTHER DEVICE. THE PHYSICIAN STEERED AROUND FOR JUST A LITTLE AND TOOK A PICTURE WHEN THE PERICARDIAL EFFUSION WAS NOTED. ONCE CONTRAST WAS SHOT INTO THE CANNULA AND THE PERICARDIAL EFFUSION WAS SHOWING, THE PATIENT STARTED DECOMPENSATING. AFTER AN HOUR OF CPR AND EPI ADMINISTERED, THE PATIENT EXPIRED. IT WAS THOUGHT THAT BECAUSE THE CANNULA WAS BARELY EXPOSED OUT OF THE OUTER SHEATH AND THE PHYSICIAN WAS TRYING TO REGAIN ACCESS, THAT THIS MAY HAVE CONTRIBUTED TO THE EVEN

  Patient problems: Pericardial Effusion

  MAUDE report 21179196 ↗
• DeathOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED A PATIENT DEATH OCCURRED DURING A PROCEDURE WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85, AS WELL AS AN AMPLATZ WIRE AND GORE DRY SEAL SHEATH; PLACED IN THE GROIN. THE PATIENT WAS, REPORTEDLY, VERY SICK PRIOR TO ATTEMPTING THE PROCEDURE AND MET THE CRITERIA FOR HIGH-RISK DUE TO A MASSIVE PULMONARY EMBOLISM (PE) AND HEART FAILURE. AFTER THE PHYSICIAN CROSSED THE R HEART WITH THE ALPHAVAC OVERSHEATH, THE PATIENT LOST THEIR BLOOD PRESSURE AND PULSE. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE BODY AND THE PATIENT HAD A DNR ORDER; THEREFORE, CPR WAS ATTEMPTED, ONLY VERY BRIEFLY. ULTIMATELY, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THAT THERE IS NO CASUAL RELATIONSHIP BETWEEN THE ALPHAVAC DEVICE AND THE PATIENT'S EXPIRATION. PRIOR TO THE PROCEDURE, THE PHYSICIAN HAD INFORMED THE PATIENT THAT SHE MAY NOT SURVIVE THE PROCEDURE DUE TO HER FRAILTY AND R HEART FAILURE. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE IFU AND THE PHYSICIAN HAS BEEN TRAINED ON THE FLOW MODEL DEMO AND ONE OTHER SUCCESSFUL ALPHAVAC CASE, WITHOUT INCIDENT. THE ANGIODYNAMICS SENIOR TERRITORY MANAGER WAS ALSO PRESENT FOR THIS CASE AND HAS BEEN P

  Patient problems: Cardiac Arrest

  MAUDE report 20464863 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THE FOLLOWING EVENT, DURING USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85: "DOCTOR (B)(6) WAS UTILIZING ALPHAVAC F18 FOR THE TREATMENT OF A PE. DURING THE CASE THE PATIENTS BLOOD PRESSURE DROPPED AND HEART RATE INCREASED. DOCTOR HAD SUSPICION OF PERFORATION AND CALLED CT SURGERY. UPON DISCUSSION AND IMAGING THEY TOOK PATIENT FOR EMERGENT SURGERY WHERE IT WAS CONFIRMED THERE WAS A PERFORATION IN THE RV OF THE HEART. DOCTOR (B)(6) STATED TO ME AFTER THE SURGERY THAT "I DO NOT BELIEVE THIS WAS DEVICE RELATED". PATIENT MADE IT OUT OF SURGERY AND IS RESPONDING WELL TO THERAPY AS OF TODAY (B)(6) 2024." DOCTOR (B)(6) HAS RECEIVED IN-SERVICE TRAINING TWICE, THE MOST RECENT TIME BEING JUST BEFORE THIS PROCEDURE; HOWEVER, THIS WAS HIS FIRST ALPHAVAC CASE. PREVIOUSLY, HE PERFORMED 2 ANGIOVAC CASES. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU).

  Patient problems: Intraoperative Cardiac Injury; Low Blood Pressure/ Hypotension; Perforation of Vessels; Tachycardia

  MAUDE report 19931963 ↗

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