Events

Recall of Device Recall StarClose

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular, Inc..

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
    37270
  • Event Risk Class
    Class 2
  • Event Number
    Z-0575-2007
  • Event Initiated Date
    2007-01-31
  • Event Date Posted
    2007-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50232
  • 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
    Vascular Closure System - Product Code DYB
  • Reason
    Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
  • Action
    On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep.

Device

Device Recall StarClose
  • Model / Serial
    Lot Numbers starting from 43034-6H to 47139-6H
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
  • Product Description
    StarClose Vascular Closure System (Clip Applier & Exchange System), || Catalog Number: 14677; || Product is manufactured by: || Abbott Vascular Inc., || 400 Saginaw Drive, || Redwood City, CA 94063
  • Manufacturer
    Abbott Vascular, Inc.

Manufacturer

Abbott Vascular, Inc.
  • Manufacturer Address
    Abbott Vascular, Inc., 400 Saginaw Dr, Redwood City CA 94063-4749
  • Source
    USFDA