AngioVac H965252810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965252810), received between May 6, 2026 and May 6, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 6, 2026Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH AN ANGIOVAC CIRCUIT WITH BUBBLE TRAP. IT WAS REPORTED THAT DURING ASSEMBLY OF THE CEC CIRCUIT FOR THROMBOASPIRATION, IT WAS FOUND THAT THE RING HAD BECOME DETACHED, PREVENTING THE NUT FROM BEING TIGHTENED AND LOOSENED TO INSERT THE MANDREL. IT WAS REPORTED THAT THIS RESULTED IN A LESS EFFECTIVE PROCEDURE AND LONGER INTERVENTION TIME. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED AN INTRAOPERATIVE IATROGENIC PULMONARY EMBOLISM DURING THE PROCEDURE, AFTER REMOVAL OF THE ANGIOVAC CATHETER, WHEN THE CLOT BECAME DISLODGED. THROMBOASPIRATION WAS THEN PERFORMED USING AN INARI DEVICE. CURRENTLY, THE PATIENT IS IN GOOD CLINICAL HEALTH AND IS TAKING ANTICOAGULANTS FOR HER BILATERAL PULMONARY EMBOLISM. THE PHYSICIAN REPORTED THAT THERE IS NO DIRECT LINK BETWEEN THE MALFUNCTION OF THE ANGIOVAC DEVICE AND THE PATIENT ADVERSE EVENT.

  Patient problems: Pulmonary Embolism

  MAUDE report 25094095 ↗

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