Vortex P5355KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787P5355K0), received between Dec 13, 2024 and Dec 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER PRODUCT, WITH MODEL NUMBER H787P5355KO, AND LOT NUMBER H787P5355K0. THE VORTEX DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED (B)(6) MEDICAL CENTER, (B)(6) FOR PORT REMOVAL DUE TO PORT MALFUNCTION. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6). DURING THE PROCEDURE, DR. (B)(6) OBSERVED THAT THE DISTAL PORTION OF THE CATHETER HAD EMBOLIZED INTO THE RIGHT ATRIUM AND WAS UNABLE TO RETRIEVE THE FRAGMENT. ON OR ABOUT (B)(6) 2024, PLAINTIFF SUCCESSFULLY UNDERWENT FRAGMENT RETRIEVAL VIA THE GROIN. THE PROCEDURE WAS PERFORMED BY DR.(B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727128 ↗
• MalfunctionDec 13, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2011, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX DEVICE, MODEL NUMBER P5355K, LOT NUMBER 526802, FOR ONGOING RED CELL EXCHANGES AND VEIN ACCESS. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD. (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO THE EMERGENCY DEPARTMENT (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF ABDOMINAL PAIN. UPON ADMISSION, AN X-RAY REVEALED THAT HER PORT HAD FRACTURED AND MIGRATED TO HER RIGHT ATRIUM, EXTENDING INFERIORLY INTO HER INFERIOR VENA CAVA (IVC) AND SUPERIORLY INTO HER SUPERIOR VENA CAVA (SVC). ON OR ABOUT (B)(6)2021, PLAINTIFF'S DEFECTIVE PORT AND CATHETER FRAGMENT WERE REMOVED BY DR. (B)(6), MD (B)(6) HOSPITAL.

  Patient problems: Abdominal Pain; Foreign Body In Patient

  MAUDE report 20926329 ↗

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