AngioDynamics 25184Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965251840), received between Jul 5, 2016 and Jul 5, 2016 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY ANGIODYNAMICS' CLINICAL SPECIALIST: ""ANGIOVAC WAS ADVANCED TO LT PA - THROMBUS REMOVED, CANNULA PULLED BACK AND LOST ACCESS TO PA (IN RV). WIRE MANIPULATED TO RT. PA AND CANNULA READVANCED FROM RV TO LEFT PA. PRESSURES BEGAN TO DROP BUT WERE MEDICALLY MANAGED. O2 SATS WERE AT 100%. CANNULA AND WIRE WERE REMOVED. IVC FILTER PLACED FROM RT. GROIN. BOTH RT. FEMORAL VEIN AND RT. IJ LINES WERE PULLED AND PRESSURED WAS HELD. THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. HEART RATE BECAME NON-EXISTANT AND CPR WAS STARTED. AFTER SEVERAL ROUNDS OF EPI AND BICARB PATIENT WAS DECLARED IN AYSTOLE. SINCE THE TEE PROBE WAS STILL IN PLACE ANESTHESIA TOOK A LOOK AT THE HEART AND SAW EFFUSION SURROUNDING IT. THE DOCTOR PUT A LONG NEEDLE INTO THE CHEST AND REMOVED A SYRINGE OF BLOOD CONFIRMING CARDIAC TAMPENADE. HE THEN PREPPED AND PERFORMED A STENOTEMY WHICH RESULTED IN THE RELEASE OF FLUID FROM AROUND THE HEART AND THE IMMEDIATE RETURN OF NORMAL SINUS RHYTHM AND AYSTOLE HEART RATE. UPON EVACUATION OF THE BLOOD, A HOLE WAS FOUND IN THE APEX OF THE RIGHT VENTRICLE WHICH WAS REPAIRED WITH A SURGICAL STITCH. ONCE PATIENT WAS DEEMED STABLE HER CHEST WAS CLOSED AND SHE WAS SENT TO THE CVOR

  Patient problems: Cardiac Arrest

  MAUDE report 5768875 ↗