Events

Recall of Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238

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
    28398
  • Event Risk Class
    Class 2
  • Event Number
    Z-0733-04
  • Event Initiated Date
    2004-02-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31767
  • 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, Intravascular - Product Code LJT
  • Reason
    Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
  • Action
    Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.

Device

Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port ...
  • Model / Serial
    791484, 791485
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Shipments were nationwide to 158 medical facilities nationwide.
  • Product Description
    Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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