Vortex SPDX-16-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787SPDX16I0), received between May 22, 2025 and May 22, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K032557); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX, MODEL NUMBER SPDX161, LOT NUMBER 4962096. THE PORT WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6). ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6), WITH CONCERNS OF NEGATIVE REACTIONS INCLUDING CHILLS AFTER ACCESSING HER PORT SITE. HER MEDICAL TEAM DETERMINED THAT SHE HAD DEVELOPED AN INFECTION, AND THAT THE PORT SHOULD BE REMOVED. ON OR ABOUT (B)(6) 2016, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), M.D., AT (B)(6).

  Patient problems: Chills; Unspecified Infection

  MAUDE report 22072573 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032557. One submission often covers many models, so check the product and lot details in each record.

• Z-0403-2011 · Sep 27, 2010 · Terminated
  Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816