Events

Recall of Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter.

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
    33858
  • Event Risk Class
    Class 2
  • Event Number
    Z-0340-06
  • Event Initiated Date
    2005-10-28
  • Event Date Posted
    2006-01-06
  • 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=42598
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    Device kits contain b. braun locking tearaway introducer systems labeled as 7fr but may contain 8 fr sheaths.
  • Action
    Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.

Device

Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter.
  • Model / Serial
    1007398, 1017115, 1018449
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
  • Product Description
    Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, MA 02472
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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