AngioVac 25188Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965251880), received between Mar 19, 2021 and Sep 7, 2023 — classified as 2 deaths.

1 other recall cover devices cleared under the same FDA submission (K142607); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142607. One submission often covers many models, so check the product and lot details in each record.

• Z-1702-2016 · Mar 21, 2016 · Terminated
  AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be