Events

Recall of Device Recall Boston Scientific Scimed Express 2 Monorail

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Scimed.

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
    25844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0711-03
  • Event Initiated Date
    2003-03-20
  • Event Date Posted
    2003-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26581
  • 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
    Stent, Coronary - Product Code MAF
  • Reason
    The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
  • Action
    Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.

Device

Device Recall Boston Scientific Scimed Express 2 Monorail
  • Model / Serial
    Lot number 5140999
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
  • Product Description
    Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

Boston Scientific Scimed
  • Manufacturer Address
    Boston Scientific Scimed, One Scimed Place, Maple Grove MN 55311-1566
  • Source
    USFDA