AngioDynamics 25185Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965251850), received between Dec 5, 2016 and Nov 13, 2018 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2018Difficult to Open or Close; Difficult to Open or Close

  AS REPORTED REGARDING A HOSPITAL IN (B)(6): " CASE: PATIENT WITH SOFT AND MOVABLE MASS IN RA. THE ANGIOVAC CANNULA DIDN'T ASPIRATE THE MASS AND IT DIDN'T REACH HIGH ASPIRATION. THREE DIFFERENT TYPES OF ACCESS HAVE BEEN TRIED. AFTER THE LAST ATTEMPT, THE PHYSICIAN TRIED TO INFLATE THE BALLOON OUTSIDE FROM THE PATIENT. WE OBSERVED THAT THE PETALS OF THE TIP DIDN'T OPEN PROPERLY AND A PETAL CLOGGED UP THE INNER LUMEN INSTEAD OF OPEN OUTWARD. SO THE INTERVENTION HAS BEEN CONVERTED IN 'OPEN APPROACH'. THE CAREGGI HOSPITAL HAS SENT A COMPLAINT TO MINISTRY OF HEALTH. " THE PATIENT CONDITION WAS REPORTED AS "STABLE." IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Thrombus

  MAUDE report 8064611 ↗
• MalfunctionSep 8, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED END USER HOSPITAL NOTED A SMALL HOLE IN THE PACKAGING OF THE ANGIOVAC CANNULA, THEREBY COMPROMISING THE STERILITY. THE DEVICE WAS NOT USED ON A PATIENT. IT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851211 ↗
• DeathJan 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY ANGIODYNAMICS' CLINICAL SPECIALIST: PATIENT'S INDICATION FOR ANGIOVAC PROCEDURE WAS RIGHT ATRIAL THROMBUS. PATIENT'S CO-MORBIDITIES WERE ENDOCARDITIS, WAS SEPTIC, AND HX OF IVDU. PATIENT WAS STABLE AT TIME OF PROCEDURE, BUT WITH HIGH VENOUS PRESSURES PER MD. PULMONARY EMBOLISM OCCURRED DURING CASE. WHEN THE PE OCCURRED IS UNKNOWN, AS THERE WAS NO VISUALIZATION OF THE EMBOLIZATION. THE PE WAS DIAGNOSED AT THE END OF THE CASE BY MD BASED ON END TIDAL CO2 AND SATURATIONS DECREASING. THE ANGIOVAC WAS OUT OF THE PATIENT AT THAT TIME. THE PATIENT'S CONDITION AT THAT TIME WAS "STABLE." FOLLOW-UP WITH THE PHYSICIAN REGARDING THE PATIENT'S CURRENT STATUS HAS INDICATED THAT THE PATIENT EXPIRED ONE WEEK AFTER THE PROCEDURE DUE TO HER OVERALL POOR HEALTH. THE MD DID NOT ATTRIBUTE THE PATIENT'S DEATH TO THE ANGIOVAC DEVICE. ((B)(4))

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6237033 ↗
• InjuryDec 5, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELDERLY PATIENT UNDERGOING ANGIOVAC THROMBECTOMY STATUS POST DVT AND AN OCCLUDED VENA CAVA. PATIENT HAD A FILTER IN PLACE WHICH WAS PLACED APPROXIMATELY 3 WEEKS PRIOR TO THE CASE. DURING THE PRE-CASE PLAN THERE WAS A DISCUSSION OF A SUPRA-RENAL FILTER TO PREVENT CLOT FROM GOING AROUND THE CANNULA AND ENDING UP IN THE PATIENT'S LUNGS. DURING THE CASE HOWEVER, THE LANDING ZONE WASN'T AMENABLE FOR THE SUPRA-RENAL IVC FILTER PLACEMENT. ACCESS POINTS FOR THIS CASE WERE RIGHT INTERNAL JUGULAR FOR ASPIRATION AND LEFT INTERNAL CANNULA FOR REINFUSION. ADDITIONALLY, THE LEFT FEMORAL VEIN WAS ACCESSED FOR IMAGING AND ANCILLARY DEVICES. INITIAL FLOW RATES WERE EXTREMELY POOR IN THE PERI-HEPATIC CAVA, ONLY 500 CC/MIN AT 1500 RPMS. ANGIODYNAMICS CLINICAL SPECIALIST VOICED HIS CONCERNS AT THIS, ESPECIALLY SINCE HE COULDN'T ACCOUNT FOR THIS EXTREMELY LOW FLOW RATE. THE PATIENT WAS THEN GIVEN A LITER OF SALINE TO INCREASE HIS CIRCULATING VOLUME. THE CASE THEN PROCEEDED WITH A FLOW RATE OF 1.5L/MIN. THE FLOW RATES CONTINUED TO BE A PROBLEM THROUGHOUT THE CASE. A CLEANER WIRE WAS USED IN THE VENA CAVA AND A FEW MINUTES LATER THE PATIENT'S END TIDAL CO2 WENT DOWN ALONG WITH HIS OXYGEN SATURATION. IMAG

  Patient problems: Thrombosis

  MAUDE report 6145665 ↗