Vortex P12105KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787P12105K0), received between Jul 11, 2017 and Jul 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K010189); 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 11, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: (B)(6) 2015: VORTEX PORT WAS IMPLANTED IN PATIENT. THE PORT BODY WAS PLACED ON RIGHT SIDE OF CHEST AND CATHETER TUNNELED UP TO INSERTION POINT OF CATHETER IN SUBCLAVIAN VEIN. (B)(6) 2016: HOSPITAL STAFF WAS UNABLE TO FLUSH THE PORT. CHEST X-RAY ON THE PATIENT ON THE SAME DAY REVEALED SEPARATION OF THE CATHETER FROM THE PORT BODY. THE CATHETER WAS COMPLETELY SEVERED FROM THE PORT AT THE POINT WHERE THE EXIT STEM OF THE PORT BODY ENDS. (B)(6) 2016: PORT AND CATHETER WERE EXPLANTED. DELAY OF EXPLANT WAS DUE TO THE PATIENT BEING UNWELL. THE PATIENT WAS THEN IMPLANTED WITH ANOTHER VORTEX PORT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6701839 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010189. One submission often covers many models, so check the product and lot details in each record.

• Z-0402-2011 · Sep 27, 2010 · Terminated
  Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
• Z-0149-2008 · Oct 3, 2007 · Terminated
  Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816