Events

Recall of Device Recall Boston Scientific/Microvasive

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
    25487
  • Event Risk Class
    Class 2
  • Event Number
    Z-0552-03
  • Event Initiated Date
    2003-01-29
  • Event Date Posted
    2003-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25918
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Breach in sterile barrrier may compromise sterility.
  • Action
    Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted.

Device

Device Recall Boston Scientific/Microvasive
  • Model / Serial
    Lot Numbers:  5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902
  • Product Classification
    Gastroenterology-Urology Devices
  • Distribution
    Nationwide
  • Product Description
    Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon || Catalog # 4545
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Place, Natick MA 01760
  • Source
    USFDA