Events

Recall of Device Recall AngioSeal

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
    35819
  • Event Risk Class
    Class 3
  • Event Number
    Z-0157-2007
  • Event Initiated Date
    2006-06-07
  • Event Date Posted
    2006-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46926
  • 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 Device - Product Code MGB
  • Reason
    The angio seal vip 6f devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
  • Action
    All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.

Device

Device Recall AngioSeal
  • Model / Serial
    Lot 1204437
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
  • 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