AngioVac 25199Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965251990), received between Dec 19, 2017 and Dec 19, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Air Leak” (1 report).

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

• InjuryDec 19, 2017Air Leak; Air Leak

  AS REPORTED, AN ANGIOVAC PROCEDURE TO REMOVE RA VEGETATION ON A PULMONALIS CATHETER WAS PERFORMED ON A PATIENT AT THE (B)(6) HOSPITAL OF (B)(6). DURING THE PROCEDURE THERE WAS "MASSIVE AIR ASPIRATION" DURING SUCTION IN THE RIGHT VENTRICLE. ALL VALVES AND STOPCOCKS WERE CLOSED AND DOUBLE CHECKED. AIR BUBBLES WERE DETECTED BY TE ECHO IN THE RIGHT ATRIUM. SHORTLY AFTER, THE PATIENT'S BLOOD PRESSURE DROPPED BUT SUFFICIENT CIRCULATION WAS ACHIEVED AFTER ONE MINUTE. THERE WERE "NO FURTHER MEDICAL ISSUES FOR THE PATIENT, " AND THEIR CONDITION WAS REPORTED AS "STABLE." THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THE USED ANGIOVAC DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Air Embolism

  MAUDE report 7128354 ↗

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