Vortex P12155KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787P12155K0), received between May 10, 2017 and Jul 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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 18, 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.

• MalfunctionJul 12, 2017Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6) REGARDING AN IMPLANTED VORTEX PORT: WHICH HAD BEEN PLACED ON (B)(6) 2017: "PRESENCE OF PERFORATION IN THE PROXIMAL PART OF THE CATHETER, IN A SEGMENT UNDER THE CATHETER CONNECTION STEM TO THE RESERVOIR. PATIENT PRESENTED OVERFLOW OF THE MEDICATION AND BULGING AT THE CATHETER SITE. A CONTRAST EXAMINATION WAS CARRIED OUT, AND IT CONFIRMED THE PRESENCE OF PERFORATION IN THE CATHETER." THE PORT WAS REMOVED AND REPLACED ON (B)(6) 2017.

  Patient problems: Swelling

  MAUDE report 6705196 ↗
• MalfunctionMay 10, 2017Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON APRIL 11, 2017: PATIENT REQUIRED A CATHETER REPLACEMENT OF TOTALLY IMPLANTABLE PORT DUE TO DYSFUNCTION. THE CATHETER OF THE REPORTED DEVICE WAS NOT INFUSING NOR FLOWING BACK. DURING THE SURGERY IT WAS NOTED THAT THE RESERVOIR DIAPHRAGM (SILICON MEMBRANE) WAS DISPLACED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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: No Known Impact Or Consequence To Patient

  MAUDE report 6556405 ↗

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