Vortex P5305KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787P5305K0), received between Jul 12, 2017 and Mar 2, 2026 — classified as 3 injuries.

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

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER P5305K AND LOT NUMBER 5163667. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) FOR LACK OF VASCULAR ACCESS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF CHEST AND NECK PAIN. BLOOD CULTURES WERE DRAWN FROM THE PORT SITE. PLAINTIFF WAS SUBSEQUENTLY DISCHARGED WITH A PRESCRIPTION FOR ANTIBIOTICS PENDING RESULTS OF THE BLOOD CULTURE. ON OR ABOUT (B)(6) 2018, PLAINTIFF RETURNED TO (B)(6) HOSPITAL IN (B)(6), DUE TO CONTINUED DISCOMFORT AND THE POSITIVE BLOOD CULTURES THAT WERE PREVIOUSLY DRAWN. SHE WAS DISCHARGED HOME ON ANTIBIOTICS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), DUE TO ISSUES WITH THE ANTIBIOTICS SHE HAD BEEN PRESCRIBED. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT AN ULTRASOUND, WHICH DEMONSTRATED A THROMBOSIS IN HER LEFT INTERNAL JUGULAR VEIN. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE VORTEX NEEDED TO BE REMOVED DUE TO INFECTION AND THROMBOSIS. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE DEVICE. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (

  Patient problems: Bacterial Infection; Chest Pain; Neck Pain; Thrombosis/Thrombus

  MAUDE report 24480053 ↗
• InjuryNov 13, 2018Fracture; Migration; Fracture; Migration

  ANGIODYNAMICS' DISTRIBUTOR IN (B)(4) WAS ADVISED BY STAFF IN OPERATING THEATRES AT A HOSPITAL IN (B)(6) THAT A VASCULAR ACCESS PORT HAD BEEN EXPLANTED (B)(6) 2018 DUE TO 'END OF THERAPY' AND DURING REMOVAL THEY DISCOVERED THAT THE PORT'S CATHETER WAS 'FRACTURED'. THE LINE WAS DISCOVERED FRACTURED DURING REMOVAL. THE PATIENT'S MOTHER HAS FLUSHED THE PORT ONCE A WEEK SINCE THE INSERTION DATE ((B)(6) 2015). ABOUT A MONTH AGO BEFORE THE SURGERY DATE, THE PORT WASN'T FLUSHING WELL AND THE PATIENT FELT AS FUNNY FEELING WHEN THE MOTHER WOULD TRY TO FLUSH IT. THE MOTHER DIDN'T REPORT IT TO THE SURGEON BECAUSE PATIENT WAS ALREADY BOOKED FOR THE PORT TO BE REMOVED, THEREFORE NO XR WAS TAKEN AS SURGEON WAS NOT AWARE UNTIL THE DAY OF THE SURGERY. SURGEON MENTIONED THAT THE PORT LINE DIDN'T BLEED AT ALL WHEN REMOVED SO SHE BELIEVES THAT THE PORT WAS FRACTURED FOR SOME TIME. HOSPITAL ADVISED THAT PATIENT WAS STABLE/OK FOLLOWING REMOVAL OF PORT WITH FRACTURED CATHETER BUT DID ADVISE: 'AS A RESULT OF THE FRACTURED PORT, THE PATIENT NEEDED AN EXTRA INCISION ON THE NECK FOR SURGEON TO FIND THE BROKEN END OF THE LINE LEADING TO MORE PAIN AND SCARRING FOR THE PATIENT'. THE PORT WILL BE FORWARDED TO AN

  Patient problems: Pain

  MAUDE report 8063626 ↗
• InjuryJul 12, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON JUNE 16, 2016: PATIENT HAD PORT PLACED IN THE LEFT SUBCLAVIAN VEIN (B)(6) 2016. THE PORT WAS BEING REMOVED ON (B)(6) 2016. UPON REMOVAL, THE PORT BODY WAS RETRIEVED SUCCESSFULLY. HOWEVER A PORTION OF THE CATHETER FRACTURED OFF AND WAS NOT RETRIEVED FROM THE VASCULATURE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL VIA AMBULANCE AND REFERRED TO IR TO RETRIEVE CATHETER. IT WAS NOTED THE PATIENT WAS NOT SYMPTOMATIC IN RECOVERY PRIOR TO TRANSFER. THE RADIOLOGIST WAS ABLE TO SUCCESSFULLY REMOVE THE CATHETER FRAGMENT AND IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. 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 6706011 ↗

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