Events

Recall of Arstasls One Access System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arstasis, 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
    57507
  • Event Risk Class
    Class 1
  • Event Number
    Z-0993-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2011-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96420
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Device has the potential to fracture and sheath separation during use.
  • Action
    The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to customerservice@arstasis.com. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.

Device

Arstasls One Access System
  • Model / Serial
    Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft || and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA || The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths.
  • Manufacturer
    Arstasis, Inc

Manufacturer

Arstasis, Inc
  • Manufacturer Address
    Arstasis, Inc, 740 Bay Rd, Redwood City CA 94063-2469
  • Manufacturer Parent Company (2017)
    Arstasis Inc.
  • Source
    USFDA