Vortex SPAX-16-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787SPAX16I0), received between Jul 12, 2017 and Jul 12, 2017 — classified as 1 malfunction.

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

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.

• MalfunctionJul 12, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016 VIA USER MEDWATCH (B)(4): PATIENT HAD A RIGHT INTERNAL JUGULAR VEIN PORT-A-CATH PLACED APPROXIMATELY 2 WEEKS PRIOR. THERE WERE NO COMPLICATIONS ON PLACEMENT AND DEVICE FLUSHED EASILY. PATIENT RECEIVED ONE ROUND OF CHEMOTHERAPY WITH DEVICE. DURING SUBSEQUENT ADMISSION, IT WAS FOUND THAT THE PORT WOULD NOT FLUSH. ON X-RAY, IT WAS DISCOVERED THAT THE CATHETER WAS FRACTURED. DEVICE WAS SUCCESSFULLY REMOVED, AND FOUND TO BE BENT, HAD PARTIALLY BROKEN THROUGH. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6706024 ↗

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