Vortex SSDX-10-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787SSDX10I0), received between Jun 20, 2018 and Jun 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K951814); 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.

• InjuryJun 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED, DURING REMOVAL OF AN IMPLANTED PORT AT KNAPP MEDICAL CENTER THE CATHETER FRACTURED. THE PORT HAD ORIGINALLY BEEN IMPLANTED ON (B)(6) 2017. THE FRACTURED PORTION OF THE CATHETER WAS REMOVED BY THE INTERVENTIONAL RADIOLOGIST AT KNAPP MEDICAL CENTER. NO PATIENT INJURY WAS REPORTED. THE USED DEVICE HAS BEEN DISCARDED AT THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7618697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951814. One submission often covers many models, so check the product and lot details in each record.

• Z-0406-2011 · Sep 27, 2010 · Terminated
  Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.