Z-0993-2011

Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of...

Name: Z-0993-2011 Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of...
Creator: Arstasis, Inc
Published: 2010-10-19
License: https://open.fda.gov/license/

Arstasis, Inc. / initiated 2010-10-19 / Terminated / root cause: design

FDA source

Arstasis, Inc began a recall of Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device... on 2010-10-19. The reason FDA records is "Device has the potential to fracture and sheath separation during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0993-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2011-02-04
Terminated: 2011-02-16
Recalling firm: Arstasis, Inc.
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: Device has the potential to fracture and sheath separation during use.
Root cause tag: design
FDA root cause: Device Design
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 [email protected]. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.
Quantity in commerce: 330 units
Distribution: Worldwide Distribution
Product codes and lots: Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)