Vortex P5455KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787P5455K0), received between Oct 18, 2017 and Feb 9, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Fracture

  ON OR ABOUT (B)(6) 2008, PLAINTIFF UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX PORT CATHETER PRODUCT, WITH MODEL NUMBER P5455K, AND LOT NUMBER 31732. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), ALABAMA FOR LONG-TERM ANTIBIOTIC THERAPY. ON OR ABOUT (B)(6) 2013, PLAINTIFF PRESENTED TO (B)(6), ALABAMA TO UNDERGO A CHEST X-RAY TO EVALUATE PLAINTIFF'S DYSPNEA (SHORTNESS OF BREATH), AND THE X-RAY REVEALED CATHETER FRACTURE. ON OR ABOUT (B)(6) 2013, PLAINTIFF PRESENTED TO (B)(6), ALABAMA TO UNDERGO RETRIEVAL OF A CATHETER FRAGMENT LOCATED IN PLAINTIFF'S RIGHT ATRIUM. THE FRAGMENT RETRIEVAL OPERATION WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT (B)(6) 2013, PLAINTIFF PRESENTED TO (B)(6), ALABAMA TO UNDERGO REMOVAL OF THE REMAINING VORTEX PORT CATHETER DEVICE. THE PROCEDURE WAS PERFORMED BY DR. (B)(6)..

  Patient problems: Dyspnea

  MAUDE report 24293997 ↗
• MalfunctionSep 18, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX TITANIUM PORT SYSTEM, WITH MODEL NUMBER P54565K, AND LOT NUMBER 5218796. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6), FOR CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6), FOR PREOPERATIVE WORKUP AND TESTING PRIOR TO UNDERGOING A COLONOSCOPY, WHICH INCLUDED A CHEST X-RAY, THAT REVEALED THE CATHETER PORTION OF THE VORTEX HAD FRACTURED AND MIGRATED. BASED ON THE X-RAY FINDINGS, ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6), TO UNDERGO REMOVAL OF THE VORTEX PORT AND THE FRACTURED CATHETER. THIS REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Failure of Implant

  MAUDE report 23088582 ↗
• MalfunctionOct 18, 2017Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), THE CATHETER PORTION OF A VORTEX PORT, RUPTURED AND HAD TO BE REMOVED. PATIENT CONDITION WAS REPORTED AS "STABLE." THE USED DEVICE WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6959503 ↗

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