Events

Recall of Vaxcel¿ Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/PU/8/1.6/2.6/63 || Catalog Number : 45-362

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
    32694
  • Event Risk Class
    Class 2
  • Event Number
    Z-1482-05
  • Event Initiated Date
    2005-07-22
  • Event Date Posted
    2005-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40598
  • 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, Suprapubic (And Accessories) - Product Code KOB
  • Reason
    The tearaway introducer sheath may have cracked hubs/handles and/or improper peeling during use.
  • Action
    Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

Device

Vaxcel¿ Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/PU/8/1.6/2....
  • Model / Serial
    Lot Numbers: 904746 905284 916199 917958 919483 920317 920762 922096 922595 922596 924197 973170  979018 1001738 922596D
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
  • Product Description
    Vaxcel¿ Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/PU/8/1.6/2.6/63 || Catalog Number : 45-362
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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