Vaxcel 45215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M001452150), received between Nov 17, 2025 and Mar 10, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• MalfunctionMar 10, 2026Fracture

  ON OR ABOUT (B)(6) 2012, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VAXCEL PORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 1333308. THE DEVICE WAS IMPLANTED AT SONY MONTGOMERY VA MEDICAL CENTER IN JACKSON, MISSISSIPPI FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021, PLAINTIFF PORT WAS NOTED TO BE FRACTURED, AND PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2021, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6) MD AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565601 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2012, PLAINTIFF UNDERWENT PLACEMENT OF A NAVILYST VAXCEL PORT CATHETER PRODUCT, WITH MODEL M001452150, AND LOT NUMBER 4415165.4 THE VAXCEL PORT IS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D, (B)(6), FOR TREATING PLAINTIFF'S LUPUS. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6), WITH SYMPTOMS OF AN INFECTION. BLOOD DRAWN FROM PLAINTIFF'S PORT WAS CULTURED, AND CAME BACK POSITIVE FOR STAPHYLOCOCCUS HOMINIS, REQUIRING REMOVAL OF THE VAXCEL PORT. ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT REMOVAL OF THE VAXCEL, AND THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. (B)(6).

  Patient problems: Bacterial Infection

  MAUDE report 24110430 ↗
• MalfunctionNov 17, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2010, PLAINTIFF UNDERWENT PLACEMENT OF THE NAVILYST VAXCEL PORT, REFERENCE NUMBER 45-215, LOT NUMBER 1377315. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD, AT (B)(6), FOR THE PURPOSE OF ONGOING INTRAVENOUS MEDICATIONS, HYDRATION, AND BLOOD DRAWS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE PLAINTIFF LEARNED THAT HER PORT WAS FRACTURED AND/OR MALFUNCTIONED. PLAINTIFF WAS MADE AWARE BY HER PHYSICIAN THAT THE PORT COULD NOT BE REMOVED. THE PORT REMAINS IN THE PLAINTIFF'S BODY. PLAINTIFF DID NOT DISCOVER THE HEIGHTENED RISK OF THE FRACTURE RELATED TO VAXCEL PORT DEFECTS UNTIL AROUND (B)(6) 2023, WHEN SHE SAW AN AD REGARDING THE ANGIODYNAMICS' DEFECTIVE PRODUCTS LITIGATION AND RETAINED THE (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 23568526 ↗