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-Cardiac Therapies dba Guidant 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
    52077
  • Event Risk Class
    Class 2
  • Event Number
    Z-1657-2009
  • Event Initiated Date
    2009-05-06
  • Event Date Posted
    2009-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82040
  • 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 MGB
  • Reason
    Potential sterility issue. internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
  • Action
    Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.

Device

Device Recall StarClose

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation
  • Manufacturer Address
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA