Vortex P5405KRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787P5405K0), received between Jul 12, 2022 and Feb 26, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2010, PLAINTIFF UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER P5405K, AND LOT NUMBER 508180. THE VORTEX WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6). THE PURPOSE OF IMPLANTATION OF THE VORTEX WAS TO ADMINISTER CHEMOTHERAPY TO TREAT PLAINTIFF'S LYMPHOMA. ON OR ABOUT (B)(6) 2014, PLAINTIFF PRESENTED TO (B)(6) WITH SYMPTOMS OF FACIAL AND UPPER NECK SWELLING, UPPER EXTREMITY SWELLING, AND RASH. PLAINTIFF SUBSEQUENTLY UNDERWENT A CT SCAN, WHICH REVEALED EVIDENCE OF THROMBUS SURROUNDING THE VORTEX PORT, REQUIRING REMOVAL OF THE DEVICE. ON OR ABOUT (B)(6) 2014, PLAINTIFF PRESENTED TO (B)(6) OUTPATIENT SURGERY IN (B)(6), TO UNDERGO REMOVAL OF DEFENDANTS' VORTEX DEVICE SECONDARY TO HER DEVELOPMENT OF THROMBOSIS AROUND THE PORT. THE REMOVAL PROCEDURE WAS PERFORMED BY (B)(6), M.D.

  Patient problems: Rash; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24465481 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS VORTEX PORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5279951. THE DEVICE WAS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY FOR CANCER. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED HERSELF TO (B)(6) MEDICAL CENTER IN (B)(6) WHERE SHE WAS ADMITTED TO THE HOSPITAL DUE TO AN INFECTION. PLAINTIFF'S DOCTORS ULTIMATELY REMOVED THE PORT AND TREATED THE INFECTION. AS A RESULT OF HAVING THE VORTEX PORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Unspecified Infection

  MAUDE report 21180173 ↗
• MalfunctionDec 4, 2023Material Puncture/Hole; Material Puncture/Hole

  AN END USER REPORTED AN ISSUE WITH A VORTEX SL TIT 9.6FR ATT SIL CATH W 10F INTR PG. IT WAS REPORTED THAT THE TUBE SYSTEM WAS FOUND TO BE LEAKING, ONCE THE PATIENT WAS RETURNED TO THEIR ROOM, DUE TO AN ACCIDENTAL PUNCTURE. IT IS BELIEVED THAT THE PUNCTURE "PROBABLY OCCURRED IN THE OPERATING ROOM DURING THE FIXATION OF THE DEVICE WITH SUTURE OR OTHERWISE COULD BE WHEN THE NURSE ADMINISTERED THE CHEMO TREATMENT THROUGH THE PORT." THE PORT WAS REMOVED AND REPLACED AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255297 ↗
• MalfunctionJul 12, 2022Crack; Crack

  AN ONCOLOGIST REPORTED AN ISSUE WITH A VTX SL TIT 9.6FR ATT SIL CATH W 10F INTR VORTEX PORT. THE PATIENT COMPLAINED OF PAIN DURING A CHEMOTHERAPY TREATMENT AND THE AREA TURNED RED. ULTIMATELY, THE PORT WAS REMOVED, AND UPON INSPECTION, A CRACK WAS OBSERVED IN THE SEPTUM. IT IS ASSUMED THAT THIS IS WHAT RESULTED IN THE EXTRAVASATION OF THE CHEMOTHERAPY AGENT. THE PORT'S FREQUENCY OF USE WAS REPORTED AS MONDAY THROUGH FRIDAY FOR THREE WEEKS. AFTER THE PORT REMOVAL THE PATIENT RECEIVED TREATMENT BY PERIPHERAL IV. IT WAS REPORTED THE PATIENT IS DOING WELL.

  Patient problems: Pain

  MAUDE report 14986645 ↗

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