AngioVac H965251940Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15051684016506), received between Mar 24, 2025 and Jun 23, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, 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 ↗