Events

Recall of Device Recall Boston Scientific Boston Scientific SpyGlass Ocular

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
    37403
  • Event Risk Class
    Class 2
  • Event Number
    Z-0697-2007
  • Event Initiated Date
    2007-02-07
  • Event Date Posted
    2007-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50491
  • 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
    Ocular - Product Code KOG
  • Reason
    Spyglass probe and ocular: ocular is out of specification and during disconnect may damage probe.
  • Action
    Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Device

Device Recall Boston Scientific Boston Scientific SpyGlass Ocular
  • Model / Serial
    Lot Number: 532202
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
  • Product Description
    Boston Scientific SpyGlass Ocular || Reference Number: 4604 UPN M00546040
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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