Events

Recall of Device Recall Guidant ACROBAT Vacuum Stabilizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Guidant Cardiac Surgery.

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
    37272
  • Event Risk Class
    Class 2
  • Event Number
    Z-0612-2007
  • Event Initiated Date
    2006-12-01
  • Event Date Posted
    2007-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50235
  • 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
    Vacuum Stabilizer - Product Code MWS
  • Reason
    Vacuum tubing failure- vacuum tubing fails before the labeled two year shelf life. this may result in partial or complete vacuum loss during surgery.
  • Action
    The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.

Device

Device Recall Guidant ACROBAT Vacuum Stabilizer
  • Model / Serial
    All products with expiry dates of June 2008, lot codes ranging from 4120281 to 6102381. See Below:  4120281 5020781 5051381 5062181 5091481 5110182 6013181 6040581 6062481 6091881 6101881 4120681 5021481 5052381 5072881 5092781 5110381 6020681 6050181 6070581 6091981 6101882 4121581 5031681 5052382 5081081 5092782 5110481 6020682 6050681 6081781 6092581 6102381 5010681 5032181 5061581 5081681 5101881 5120181 6022181 6051881 6081782 6092582 5011881 5040681 5061681 5081781 5101981 5120281 6030681 6052081 6081881 6101181 5012881 5041881 5061781 5081782 5101982 6010481 6030781 6060981 6083081 6101681 5020381 5050281 5062081 5081881 5110181 6011981 6040481 6061981 6083181 6101682
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.
  • Product Description
    Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
  • Manufacturer
    Guidant Cardiac Surgery

Manufacturer

Guidant Cardiac Surgery
  • Manufacturer Address
    Guidant Cardiac Surgery, 3200 Lakeside Dr, Santa Clara CA 95054-2807
  • Source
    USFDA