Events

Recall of Device Recall Boston Scientific

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-1474-05
  • 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=40589
  • 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

Device Recall Boston Scientific
  • Model / Serial
    Lot Numbers: 919480 924195 924850 929107  932116 936291 938095 940273 943742 945847 946253 958508  958814 959674 968282 969954 971538 973971 977485 979329  985139 986238 1001735 1001736 1001737 1003619 1004053 1007397 959674D 969954D
  • 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 Mini/T/PU/8/1.6/2.6/63 || Catalog Number : 45-220
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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