Events

Recall of Vaxcel Implantable Chest Ports with PASV Valve Technology

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

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
    37442
  • Event Risk Class
    Class 2
  • Event Number
    Z-0630-2007
  • Event Date Posted
    2007-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50557
  • 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
    Implantable Vascular Access System - Product Code LJT
  • Reason
    Sterile barrier may have been compromised. firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
  • Action
    On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. Distribution Center, Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the user, and mailed or faxed back to Boston Scientific.

Device

Vaxcel Implantable Chest Ports with PASV Valve Technology
  • Model / Serial
    Lots 1137363, 1137364, 1137733, and 1137734
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA