AngioVac 25193Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965251930), received between Jul 15, 2020 and Dec 16, 2022 — classified as 2 deaths, 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED A WIRE PERFORATION OCCURRED DURING A PROCEDURE. A PATIENT WAS ADMITTED FOR REMOVAL OF LARGE RIGHT VENTRICULAR MASS. THE PATIENT WAS BROUGHT INTO THE HYBRID ROOM AND PLACED SUPINE ON THE PROCEDURAL TABLE. GENERAL ANESTHESIA WAS ADMINISTERED, AND THE PATIENT'S RIGHT NECK AND BILATERAL GROINS, PREPPED AND DRAPED IN A STERILE MANNER. PRE-PROCEDURE: TRANSESOPHAGEAL ECHO (TEE) REVEALED A LARGE MASS IN THE RIGHT VENTRICLE. ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN (RIJ) WITH A 22FR GORE DRYSEAL. A 16FR ARTERIAL RETURN CANNULA WAS PLACED AND SECURED IN THE RIGHT FEMORAL VEIN.  THE PHYSICIAN STATED HE WANTED TO USE THE ANGIOVAC FOR THIS PROCEDURE. THE 22FR GORE DRYSEAL WAS REMOVED AND A 26FR GOREDRYSEAL WAS SUCCESSFULLY PLACED IN THE RIGHT IJ. THE 16FR RETURN CANNULA WAS ATTACHED TO THE PRIMED ANGIOVAC CIRCUIT. AN AMPLATZ SUPER STIFF WIRE WAS PLACED IN THE INFERIOR VENA CAVA (IVC). THE C20 ANGIOVAC WAS PREPPED AND ATTACHED TO THE PRIMED CIRCUIT AND FLUSHED FORWARD PRIOR TO INTRODUCTION OVER THE WIRE INTO THE 26FR GORE DRYSEAL. THE ANGIOVAC WAS INTRODUCED OVER THE AMPLATZ SUPER STIFF WIRE INTO THE IVC. THE FUNNEL WAS DEPLOYED AND THE

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 15996038 ↗
• DeathApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SPECIALIST REPORTED THAT A PATIENT WAS BEING TREATED WITH AN ANGIODYNAMICS ANGIOVAC C20 DEVICE TO ATTEMPT REMOVAL OF A 2.5CM VEGETATION ON THE VENTRICULAR SIDE OF THE PATIENT'S PULMONIC VALVE. THE RIGHT INTERNAL JUGULAR WAS ASSESSED WITH A MICROPUNCTURE KIT AND A 6FR SHEATH WAS PLACED. THE ANGIOVAC C20 WAS PLACED OVER AN AMPLATZ SUPER STIFF WIRE, THE WIRE AND DILATOR WERE REMOVED, AND THE CANNULA WAS CLAMPED. THE PHYSICIAN ELECTED TO NOT UTILIZE A BALLOON TIP CATHETER TO ACCESS THE PULMONARY ARTERY TRUNK. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS AT ACCESSING THE PULMONARY ARTERIES WITH THE AMPLATZ SUPER STIFF WIRE, THE PHYSICIAN ELECTED TO PLACE A GLIDEWIRE AND GLIDE CATHETER INTO THE PULMONARY ARTERY AND EXCHANGE THE WIRE WITH AN AMPLATZ SUPER STIFF WIRE. AFTER THE WIRE EXCHANGE, THE ANGIOVAC WAS ADVANCED INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), AND BOTH THE WIRE AND THE OBTURATOR WERE REMOVED. WHILE REMOVING THE OBTURATOR, THE ANGIOVAC CANNULA WAS PULLED BACK INTO THE RIGHT VENTRICLE AND THE PHYSICIAN ELECTED TO EXPOSE THE FUNNEL TO COMPARE LOCATION OF THE ANGIOVAC AND THE VEGETATION. IT WAS CONFIRMED THE ANGIOVAC WAS NOT IN THE RIGHT VENTRICULAR OUTFLOW TRACT, AND

  Patient problems: Cardiac Arrest

  MAUDE report 14140565 ↗
• DeathJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN INCIDENT DURING AN ANGIOVAC CASE. AT THE BEGINNING OF THE CASE, A TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS PLACED,AND THE FOUR CHAMBERS OF THE PATIENT'S HEART WERE VISUALIZED. POROUS MATERIAL APPEARED TO FILL MOST OF THE RIGHT ATRIUM (RA) AND A PATENT FORAMEN OVALE (PFO) WAS VISUALIZED. THE PHYSICIAN WAS AWARE OF THE RISKS ASSOCIATED WITH PERFORMING AN ANGIOVAC (AV) PROCEDURE WITH A PFO PRESENT AND THE POTENTIAL FOR MATERIAL TO EMBOLIZE ACROSS IT TO THE LEFT HEART AND BRAIN; HOWEVER, USING AV C20 TO DEBULK ,BASED ON THE POROUS COMPOSITION, SEEMED REASONABLE TO THE CLINICAL TEAM. THE PATIENT WAS PREPPED, AND THE RIGHT INTERNAL JUGULAR VEIN WAS ACCESSED. RIGHT FEMORAL VEIN (RFV) AND LEFT FEMORAL VEIN (LFV) ACCESS WERE OBTAINED WITH MICROPUNCTURE AND ULTRASOUND GUIDANCE. THE AV CIRCUIT WAS THEN PRIMED, RUN AND CONFIRMED TO BE FREE OF AIR. THE CIRCUIT WAS ATTACHED TO THE REINFUSION CANNULA AND THE AV AND INSERTED INTO THE RFV. BASELINE AND THRESHOLD FLOWS WERE ESTABLISHED IN THE INFERIOR VENA CAVA (IVC)/RIGHT ATRIUM (RA) JUNCTION AT ROUGHLY 3/LPM. THE PHYSICIAN ADVANCED THE AV TOWARDS THE RA TO ENGAGE THE MATERIAL OVER THE WIRE, I

  Patient problems: Death

  MAUDE report 10276856 ↗