Events

Recall of RunWay

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
    30405
  • Event Risk Class
    Class 2
  • Event Number
    Z-0454-05
  • Event Initiated Date
    2004-10-29
  • Event Date Posted
    2005-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35814
  • 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, Percutaneous - Product Code DQY
  • Reason
    The runway guide catheter do not meet internal product specifications. specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. this condition could have the potential to damage a poba or stent delivery system balloon.
  • Action
    On 10/29/04 the Boston Scientific Sales force was notified via voice mail of the recall. Sales personnel were told to contact their accounts/customers by the end of the business day on 11/02/04. Accounts/customers were to receive written notice of the recall via Fed Ex on Monday 11/01/04. Sales Personnel are to ensure that accounts/customers got notice of the recall, understand instructions and are taking appropriate steps. Catheters are to be returned to Boston Scientific Corporation, Quincy, MA.

Device

RunWay
  • Model / Serial
    all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Throughout United States and into 15 other countries.
  • Product Description
    RunWay 6F Cardiovascular Guide Catheter.
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

Boston Scientific Scimed
  • Manufacturer Address
    Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA