Events

Recall of Device Recall Vaxcel Low Profile plastic port (nonvalved)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32167
  • Event Risk Class
    Class 2
  • Event Number
    Z-0945-05
  • Event Initiated Date
    2005-06-08
  • Event Date Posted
    2005-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39282
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Port & Catheter, Implanted, Subcutaneous, Intraperitoneal - Product Code LLD
  • Reason
    Potential for port housing separation after implantation.
  • Action
    A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.

Device

Device Recall Vaxcel Low Profile plastic port (nonvalved)
  • Model / Serial
    791550, 915867, 1010168, 1017745, 1022134, 1022488, 1024234, 1038298, 791550D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Product shipped to 56 medical facilities throughout the U.S.
  • Product Description
    Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA