AngioVacRecalls & reported problems across all models

We found 5 models of AngioVac by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2017 and Jun 23, 2025 — classified as 12 deaths, 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 AngioVac problems

AngioVac models

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

• AngioVac 25194

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  7 deaths16 reports
• AngioVac 25193

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  2 deaths3 reports
• AngioVac H965251940

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 death2 reports
• AngioVac 25188

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 deaths2 reports
• AngioVac 25199

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  1 report

Recent AngioVac adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN ANGIOVAC C180 WITH OBTURATOR P. DURING A PROCEDURE, THE PHYSICIAN NOTICED A SMALL DOT IN IVC. THE ANGIOVAC CANNULA WAS REMOVED FROM THE PATIENT AND ONE MISSING RADIOPAQUE MARKER FROM ONE OF THE OVERSHEATH PEDAL, WAS LOCATED IN THE PATIENT. THE PHYSICIAN CONTINUED TO USE THE CANNULA AND ATTEMPTED TO REMOVE THE DOT FROM THE IVC BUT WERE UNSUCCESSFUL; HOWEVER, THERE WAS NO CONCERN WITH LEAVING THE MARKER IN SITU. THE PROCEDURE WAS COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY HARM OR ADVERSE EFFECTS AS A RESULT OF THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22307349 ↗
• DeathMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED A PATIENT DEATH THAT OCCURRED DURING USE OF AN ANGIOVAC C180 WITH OBTURATOR PG AND CIRCUIT WITH BUBBLE TRAP. THE FOLLOWING WAS REPORTED: "PATIENT HAD HISTORY OF CANCER 2018 (CERVICAL CANCER), ATRIAL FIBRILLATION, COPD, CTEPH, AND DVT. PATIENT HAD BLOOD IN URINE IN (B)(6) AND WAS TAKEN OFF XARELTO. INSTRUCTED TO BEGIN XARELTO AGAIN AFTER 5 DAYS. PATIENT FAILED TO BEGIN TAKING XARELTO AGAIN AS INSTRUCTED. YESTERDAY PATIENT PRESENTED AT ED AT (B)(6) WITH SUSPECTED PULMONARY EMBOLISM. PATIENT WAS TRANSFERRED TO DEACONESS GATEWAY FOR TREATMENT. CT SCAN SHOWED SMALL SADDLE EMBOLI AS WELL AS EMBOLI IN LEFT PULMONARY ARTERY THAT WASN'T DEEMED CLINICALLY SIGNIFICANT PER DR. (B)(6) . TEE SHOWED LARGE RA MASS (GREATER THAN 4CM). MASS APPEARED TO BE BROAD BASED, CONCENTRIC, AND LACKING JAGGED EDGES. SMALLER CLOT (2CM) APPEARED TO BE PRESENT AT THE IVC/RA JUNCTION. PATIENT HAD BEEN INTUBATED DURING THE TEE AND HAD REMAINED INTUBATED SINCE. DR. (B)(6), CT SURGEON, SUSPECTED CARDIAC TUMOR BASED ON CONVERSATIONS IN THE CONTROL ROOM AND HE MENTIONED THE RISK OF EMBOLIZATION AND MASSIVE PE TO DR. (B)(6). PRIOR TO CASE BEGINNING, DR.(B)(6) MET WITH ADAM DAV

  Patient problems: Pulmonary Embolism

  MAUDE report 21676884 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED A PATIENT ADVERSE EVENT THAT WAS DISCOVERED IMMEDIATELY FOLLOWING A SUCCESSFUL PROCEDURE WITH AN ANGIOVAC C180 WITH OBTURATOR PG. A POST PROCEDURE ECHOCARDIOGRAM WAS PERFORMED AND SHOWED A PERICARDIAL EFFUSION. THIS REQUIRED THE PHYSICIAN TO OPEN THE PATIENT FOR REPAIR AND TO PLACE A DRAIN. THE PHYSICIAN BELIEVES THE PLEURAL EFFUSION MAY BE THE RESULT OF A WIRE PERFORATION THAT OCCURRED DURING INSERTION OF THE WIRE BECAUSE THE HOLE IN THE PATIENT WAS 'NOT LARGE;' HOWEVER, THIS IS NOT CONFIRMED. CURRENTLY, THE PATIENT IS DOING WELL. THE PHYSICIAN HAS BEEN USING ANGIOVAC DEVICES FOR 5 YEARS AND IS A VERY EXPERIENCED USER. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU).

  Patient problems: Pleural Effusion

  MAUDE report 20906758 ↗
• DeathOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED THE FOLLOWING PATIENT ISSUE DURING AN ALPHAVAC PROCEDURE: "A 59-YEAR-OLD FEMALE WITH A HISTORY OF CANCER AND CONCERN FOR METASTASIS PRESENTED WITH MATERIAL IN THE IVC EXTENDING INTO THE RIGHT ATRIUM. IN THE PRE-CASE PLANNING DISCUSSION, THE PHYSICIAN STATED THAT THERE WOULD BE TWO PARTS OF THE PROCEDURE. IN PART ONE, THE CT SURGEON WOULD USE ANGIOVAC TO ASPIRATE MATERIAL IN THE RIGHT ATRIUM. HE PLANNED TO ACCESS THE RIGHT INTERNAL JUGULAR VEIN FOR ASPIRATION WITH ANGIOVAC AND THE LEFT INTERNAL JUGULAR VEIN FOR THE BLOOD RETURN CANNULA. IN PART TWO, THE VASCULAR SURGEON WOULD USE ALPHAVAC TO ASPIRATE MATERIAL IN THE IVC. HE PLANNED TO ACCESS THE RIGHT FEMORAL VEIN FOR ASPIRATION. THE PATIENT WAS BROUGHT TO THE OR FOR THE PROCEDURE. PREPROCEDURAL VITALS WERE STABLE. THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. TEE PROBE WAS INTRODUCED AND CONFIRMED MOVEABLE MATERIAL IN THE RIGHT ATRIUM EXTENDING DOWN INTO IVC. THE ANGIOVAC CIRCUIT WAS PREPPED AND PRIMED. THE CT SURGEON USED ULTRASOUND GUIDANCE TO GAIN ACCESS INTO THE RIGHT AND LEFT INTERNAL JUGULAR VEINS AND PLACED A SMALL BORE SHEATH IN EACH VEIN. THE PATIENT WAS GIVEN HEPARI

  Patient problems: Perforation of Vessels

  MAUDE report 18041484 ↗
• DeathSep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED A PATIENT DEATH, FOLLOWING AN ANGIOVAC PROCEDURE. THE PATIENT HAD BEEN EXPERIENCING SIGNIFICANT AND ONGOING CARDIOVASCULAR ISSUES WHEN THEY RECEIVED A CHEST CT ON (B)(6) 2023 THAT DEMONSTRATED MULTIPLE NODULAR DENSITIES, SOME WITH CAVITARY APPEARANCE. A TRANSTHORACIC ECHO WAS THEN REPEATED, REVEALING NEW, LARGE, MOBILE ECHODENSITY ON THE PACEMAKER WIRE. THIS WAS LOCATED WITHIN THE RIGHT VENTRICLE, MEASURING 1.5 X .2 CM. CONSEQUENTLY, THE PATIENT WAS TRANSFERRED TO (B)(6) FOR PACEMAKER SYSTEM EXTRACTION; HOWEVER, SHORTLY AFTER ARRIVAL, RAPID ESCALATION OF PRESSOR SUPPORT AND INTUBATION FOR WORSENING RESPIRATORY DISTRESS WAS REQUIRED. ELECTROPHYSIOLOGY WAS CONSULTED FOR PACEMAKER SYSTEM EXTRACTION AND THE PATIENT UNDERWENT AN ANGIOVAC PROCEDURE WHERE THE PATIENT WAS TREATED FOR LEAD EXTRACTION/ RVOT CLOT. ULTIMATELY, THE PATIENT EXPIRED AFTER THE PROCEDURE, AS A RESULT OF VENTRICULAR FIBRILLATION. THE PATIENT'S CO-MORBIDITIES ARE BELIEVED TO BE A CONTRIBUTING FACTOR IN THEIR EXPIRATION. THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION/ DEFICIENCY AND THE PHYSICIAN DOES NOT BELIEVE THE PATIENT'S DEATH WAS RELATED TO ANY ANGIODYNAMICS DEV

  Patient problems: Exsanguination; Ventricular Fibrillation

  MAUDE report 17700430 ↗
• DeathJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED A PATIENT ADVERSE OUTCOME, FOLLOWING AN ANGIOVAC PROCEDURE. THE ANGIOVAC C180 WAS CHOSEN TO REMOVE TRICUSPID VALVE VEGETATION IN A CHRONICALLY ILL PATIENT. THERE WAS NO DEVICE MALFUNCTION AND THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE IFU (INSTRUCTIONS FOR USE.) THE ANGIOVAC WAS REPORTED TO HAVE BEEN VERY SUCCESSFUL IN REMOVING VEGETATION AND PERFORMED AS INTENDED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE; HOWEVER, 6 HOURS FOLLOWING COMPLETION, THE PATIENT EXPERIENCED A PULMONARY BLEED/ HEMORRHAGE. THE PATIENT RECOVERED UNTIL A SECOND HEMORRHAGE OCCURRED APPROXIMATELY 24 HOURS LATER, RESULTING IN THE PATIENT ULTIMATELY EXPIRING. PATIENT WAS REPORTED TO BE AN IV DRUG USER WITH SEVERAL COMORBIDITIES INCLUDING: INFECTIVE ENDOCARDITIS OF TRICUSPID VALVE CAUSING STENOSIS OF PROSTHETIC VALVE, HIV, HEPATITIS C, MRSA AND MULTIPLE LUNG ABSCESSES AS A RESULT OF "THROWING" A BLOOD CLOT. THE PHYSICIAN BELIEVES THAT THE ADVERSE OUTCOME IS A RESULT OF THE PATIENT'S MULTIPLE COMORBIDITIES AND IS UNRELATED TO THE ANGIODYNAMICS DEVICE.

  Patient problems: Exsanguination

  MAUDE report 17364255 ↗
• DeathJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SPECIALIST REPORTED AN THAT DURING A PROCEDURE AND POST USE OF AN ANGIOVAC C180 WITH OBTURATOR, THE PATIENT EXPIRED. THERE WAS NO DEVICE MALFUNCTION AS THE ANGIOVAC DEVICE PORTION OF THE PROCEDURE HAD BEEN SUCCESSFUL. 76/F PRESENTED WITH SHORTNESS OF BREATH FOR SEVERAL MONTHS. FOUND TO HAVE CLOT COMPLETELY OCCLUDING THE RIGHT PULMONARY ARTERY AND A LARGE CLOT IN TRANSIT IN THE RIGHT ATRIUM. DR. (B)(6) REACHED OUT TO US FOR REMOVAL OF RIGHT ATRIAL CLOT IN TRANSIT AND POSSIBLE REMOVAL OF PULMONARY EMBOLISM. STATED HE WANTED TO USE ANGIOVAC FOR PE DUE TO PATIENT'S POOR RENAL FUNCTION AND INABILITY TO TOLERATE CONTRAST. I INFORMED DR. (B)(6) THAT PE PORTION OF CASE WOULD BE AN OFF-LABEL USE OF THE DEVICE AND HE WISHED TO PROCEED ANYWAY. PATIENT WAS TAKEN TO CATH LAB AT (B)(6) HOSPITAL ON (B)(6)2023. PLAN WAS FOR LEFT FORMAL VEIN REINFUSION USING 17F CANNULA, RIGHT IJ ACCESS WITH 26F SHEATH FOR ASPIRATION WITH THE ANGIOVAC C180 CANNULA. THE RIGHT FEMORAL VEIN AND ARTERY WERE ACCESSED FOR ECMO CANNULATION, WHICH DR. (B)(6) BELIEVED TO BE POSSIBLY NEEDED DURING THE PROCEDURE DUE TO THE PATIENT'S POOR CONDITION. ALL ACCESS WAS GAINED WITHOUT ISSUE AFTER ACT CONFIRMED >300. PATIE

  Patient problems: Aneurysm; Cardiac Arrest

  MAUDE report 17071834 ↗
• DeathMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS' CLINICAL SPECIALIST REPORTED AN ADVERSE EVENT THAT OCCURRED DURING A PROCEDURE USING AN ANGIOVAC C180 WITH OBTURATOR. 44 YO FEMALE WITH A HISTORY OF SLEEVE GASTRECTOMY, ESOPHAGEAL ULCERS, UPPER GASTROINTESTINAL BLEED, PRIOR COLON PERFORATION (B)(6) 2023) S/P COLECTOMY, AND RECENT ADMISSION (B)(6) 2023) FOR PE WITH SEPTIC EMBOLI AND AKI. DURING HER PREVIOUS ADMISSION (B)(6) 2023) PATIENT WAS FOUND TO HAVE RIGHT-SIDED ENDOCARDITIS WITH LARGE VEGETATION IN THE CORONARY SINUS WHICH WAS MEDICALLY MANAGED. IN THE CURRENT ADMISSION, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE WAS FOUND TO BE TACHYCARDIC AND HYPOTENSIVE AND ADMITTED TO THE MICU FOR HYPOTENSION AND ANEMIA WITH A CONCERN FOR UPPER GASTROINTESTINAL BLEEDING. THE PATIENT RECEIVED AN EGD AND CTA WITH NO BLEEDING SOURCE IDENTIFIED. THE PATIENT RECEIVED A TTE WHICH CONFIRMED THE PRESENCE OF RIGHT ATRIAL MATERIAL. INTERVENTIONAL CARDIOLOGY WAS CONSULTED FOR THROMBECTOMY PROCEDURE. THE PATIENT WAS BROUGHT TO THE HYBRID OR FOR ANGIOVAC PROCEDURE. THE PATIENT CAME FROM THE MICU AND WAS INTUBATED AND SEDATED. THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. A TEE PROBE

  Patient problems: Cardiac Arrest; Decreased Respiratory Rate; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16933209 ↗
• DeathMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS' CLINICAL SPECIALIST REPORTED A PATIENT DEATH DURING A PROCEDURE IN WHICH AN ANGIOVAC C180 WITH OBTURATOR AND CIRCUIT WITH BUBBLE TRAP WERE BEING USED. AS REPORTED: MALE PATIENT, BROUGHT INTO OR6 FOR AN ANGIOVAC LEAD MASS REMOVAL, FOLLOWED BY A LASER LEAD EXTRACTION. ANESTHESIA SET UP THEIR LINES AND ACCESSES (IJ). DR. HIBBERT AND FELLOW, AS WELL AS EP PHYSICIAN SCRUBBED IN TO GAIN THEIR FEMORAL ACCESSES. ANESTHESIA ASKED FOR PADS, DUE TO ARRYTHMIA AND HYPOTENSION OF PATIENT, THEY WERE NOT USED. 26F GORE DRY-SEAL SHEATH WAS INSTALLED, FOLLOWED BY THE REINFUSION CANNULA. PERFUSION PRIMED THE ANGIOVAC CIRCUIT. THE ANGIOVAC CANNULA WAS THEN ATTACHED TO THE CIRCUIT, AND THE REINFUSION CANNULA WAS ALSO ATTACHED TO THE CIRCUIT. THE CANNULA WAS INSERTED INTO THE PATIENT, THE INTRODUCER AND GUIDEWIRE WERE REMOVED, THE FUNNEL WAS EXTENDED, AND THE CENTRIFUGAL PUMP WAS TURNED ON SLOWLY. ONCE HEMODYNAMICS WERE CONFIRMED STABLE, AND THE CIRCUIT NO LONGER CONTAINED ONLY SALINE, THE PHYSICIANS PROCEEDED TO ASK PERFUSION TO INCREASE THE FLOW OF THE CIRCUIT, AND ADVANCE THE FUNNEL TO THE MASS. THE MASS WAS VISIBLY BEING REDUCED. PERFUSION AND MYSELF (CLINICAL SPECIALIST) NOTED THE

  Patient problems: Cardiac Arrest

  MAUDE report 16897001 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN ANGIOVAC C180 WITH OBTURATOR. A 77-YEAR-OLD FEMALE PRESENTS WITH MYXOMA IN THE RIGHT ATRIUM. THE PATIENT WAS BROUGHT INTO THE CATH LAB FOR ANGIOVAC PROCEDURE. THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. TEE PROBE WAS INTRODUCED AND CONFIRMED MYXOMA ON THE FREE WALL OF THE RIGHT ATRIUM. PRE-PROCEDURE VITALS BP 114/59 (78), HR 50 NSR, SPO2 99%. THE ANGIOVAC CIRCUIT WAS PREPPED AND PRIMED. A MICROPUNCTURE KIT AND ULTRASOUND GUIDANCE WERE USED TO PLACE ONE 6F SHEATH IN THE RIGHT FEMORAL VEIN AND TWO 6F SHEATHS IN THE LEFT FEMORAL VEIN. THE PATIENT WAS GIVEN HEPARIN TO ACHIEVE AN ACT OF 300. THE RIGHT FEMORAL VEIN SHEATH WAS UPSIZED TO A 26F GORE DRYSEAL AND ONE OF THE LEFT FEMORAL VEIN SHEATHS WAS UPSIZED TO A 17F ARTERIAL RETURN CANNULA. A BOSTON SCIENTIFIC "CAPTIVATOR" SNARE WAS PLACED THROUGH THE 6F SHEATH IN THE LEFT FEMORAL VEIN. THE SNARE WAS PLACED AROUND THE 26F GORE DRYSEAL. THE ANGIOVAC CANNULA WITH OBTURATOR WAS PLACED IN THE BODY THROUGH THE 26F GORE DRYSEAL OVER A STIFF WIRE. WIRE AND DILATOR WERE REMOVED FROM THE ANGIOVAC CANNULA. THE ANGIOVAC CANNULA WAS ADVANCED FORWARD TO EXPOSE TH

  Patient problems: Perforation of Vessels

  MAUDE report 16755040 ↗
• 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 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN ANGIOVAC C180 DEVICE. THE PATIENT WAS BROUGHT INTO ROOM AND TEE PERFORMED. TEE IDENTIFIED THE MATERIAL ON THE TRICUSPID VALVE. PRE-CASE, THE PATIENT SATS WERE IN 70'S, HYPOTENSIVE, AND SUFFERING FROM CARDIOGENIC SHOCK. THE PATIENT WAS PREPPED IN STERILE FASHION. ACCESS ATTEMPTED IN RIJ WITH NO SUCCESS, SO THE PHYSICIAN DECIDED TO GO RIGHT FEMORAL VEIN FOR ASPIRATION AND LEFT FEMORAL VEIN FOR RETURN. UPON GAINING ACCESS, THE PHYSICIAN WAS UNABLE TO GET 26FR GORE DRYSEAL TO FIT THE RIGHT FEMORAL VEIN SO HE DECIDED TO PLACE THE RETURN THERE AND THE 26FR GORE DRY SEAL IN THE LEFT FEMORAL VEIN. HEPARIN WAS ADMINISTERED, AND ACT WAS ABOVE 300. ANGIOVAC CONNECTIONS WERE ESTABLISHED AND EVERYTHING WAS CONFIRMED TO BE AIR FREE. ANGIOVAC WAS INSERTED IN THE PATIENT AND POSITIONED ABOVE TRICUSPID VALVE MATERIAL. THE PUMP WAS TURNED ON AND ANGIOVAC BEGAN TO DEBULK THE MATERIAL. AS THEY WENT UP ON FLOWS, MATERIAL WAS STILL CONTINUING TO BE DEBULKED AND SUDDENLY PHYSICIAN REALIZED O2 SATS DROPPED AND COULDN'T FEEL PULSE. THE ANGIOVAC WAS IMMEDIATELY PULLED INTO IVC, EPINEPHRINE GIVEN, AND CPR BEGAN. THE PATIENT APPEARE

  Patient problems: Cardiac Arrest; Decreased Respiratory Rate; Pulmonary Embolism

  MAUDE report 13257472 ↗
• DeathMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SERVICES MANAGER REPORTED A PATIENT DEATH, AFTER PROCEDURE WITH AN ANGIOVAC CIRCUIT. THE FOLLOWING WAS REPORTED: (B)(6) FEMALE WITH HISTORY OF IV DRUG ABUSE WHO WAS IN VERY POOR HEALTH ACCORDING TO THE PHYSICIAN WAS CHOSEN FOR ANGIOVAC DEBULKING OF A LARGE TRICUSPID VALVE VEGETATION THAT HAD BOTH AN ATRIAL COMPONENT AND A SUB-VALVULAR COMPONENT. DURING THE INITIAL PROCEDURE OF USING THE ANGIOVAC DEVICE TO REMOVE VEGETATION FROM THE TRICUSPID VALVE, THE PATIENT EXPERIENCED A SHORT PERIOD OF LOW BLOOD PRESSURE AND LOW OXYGEN LEVELS. ALL OF THE MATERIAL ON THE ATRIAL SIDE OF THE VALVE APPEARED TO HAVE BEEN REMOVED AT THIS POINT AND A LARGE AMOUNT OF MATERIAL WAS VISIBLE IN THE BUBBLE TRAP. THE PROCEDURE WAS PAUSED AT THE PHYSICIAN'S DIRECTION AND ANESTHESIA TREATED THE LOW BLOOD PRESSURE AND LOW OXYGEN LEVEL WITH MEDICATION. THE PATIENT ALSO REQUIRED CARDIOVERSION FOR AN ATRIAL ARRYTHMIA. THE BLOOD PRESSURE IMPROVED AND THE ANGIOVAC PROCEDURE WAS CONTINUED. THE PATIENT'S OXYGEN LEVEL REMAINED LOW AND WAS IN THE MID 80% SATURATION RANGE. MATERIAL ON THE VENTRICULAR SIDE OF THE VALVE WAS THEN ATTEMPTED TO BE REMOVED. NUMEROUS PASSES WITH THE CANNULA ON BOTH THE

  Patient problems: Pulmonary Embolism

  MAUDE report 11528414 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED THE FOLLOWING EVENT, DURING A PROCEDURE, WITH AN ANGIOVAC CANNULA: "(B)(6) YO FEMALE PATIENT. POST CABG IN DECEMBER. PATIENT HAD EXISTING PULMONARY EMBOLUS AND CHRONIC RA THROMBUS. PATIENT ALSO HAD HEPARIN INDUCED THROMBOCYTOPENIA AND WAS ON ARGATROBAN. DURING ANGIOVAC PROCEDURE IN THE RIGHT ATRIUM, UIM OCCLUDED THE FUNNEL TIP. THE TEE SHOWED THAT THE MATERIAL WAS ON THE FUNNEL AND THAT THE RIGHT ATRIUM WAS CLEAR. THE PHYSICIANS REMOVED THE ANGIOVAC AND THE GORE DRY SEAL WHILE ON PUMP/SUCTION. DURING THIS PROCESS, THE MATERIAL DISLODGED AND COULD BE SEEN TUMBLING IN THE RIGHT ATRIUM, THEN QUICKLY EMBOLIZED TO THE LUNGS. ANGIOVAC WAS REMOVED AND THE INARI FLOWTRIEVER WAS INSERTED TO TRY AND CHASE THE PULMONARY EMBOLUS. THEY WERE UNSUCCESSFUL AND DURING THIS TIME THE PATIENT'S OXYGEN SATURATION BEGAN TO DROP AND THEY CODED THE PATIENT AND BEGAN COMPRESSIONS. THEY WERE DISCUSSING AND PREPARING TO GO INTO AN OPEN PROCEDURE ON THE PATIENT TO REMOVE THE EMBOLUS AS WE STEPPED OUT OF THE ROOM. THE FOLLOWING DAY, THE SALES REP RECEIVED INFORMATION FROM ONE OF THE PERFORMING PHYSICIANS THAT THE PATIENT WAS STABLE, ON ECMO, AND AWAKE/ALERT." THE D

  Patient problems: Pulmonary Embolism

  MAUDE report 11387199 ↗

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