Events

Recall of Device Recall AngioSeal Vascular Closure Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical / Daig Division.

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
    33329
  • Event Risk Class
    Class 2
  • Event Number
    Z-0677-06
  • Event Initiated Date
    2005-08-22
  • Event Date Posted
    2006-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41704
  • 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
    Device, Hemostasis, Vascular - Product Code MGB
  • Reason
    Mispackaging-some angio-seal 6f sts vascular closure devices from lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
  • Action
    Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.

Device

Device Recall AngioSeal Vascular Closure Device
  • Model / Serial
    Lot number 1146548
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    International Only-Belgium, China, Guadalajara, New Zealand and Thailand.
  • Product Description
    Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
  • Manufacturer
    St. Jude Medical / Daig Division

Manufacturer

St. Jude Medical / Daig Division
  • Manufacturer Address
    St. Jude Medical / Daig Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • Source
    USFDA