Arstasis, Inc: 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.

Recall number

Z-0993-2011

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.

Status

Terminated

Initiated

2010-10-19

Posted

2011-02-04

Terminated

2011-02-16

Reason

Device has the potential to fracture and sheath separation during use.

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 customerservice@arstasis.com. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.

Quantity

330 units

Distribution

Worldwide Distribution

Lot, serial or model codes

Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334

510(k) numbers

["K091006","K100615","K102728"]

PMA numbers

not on file

Product code

DYB

Firm FEI

3008493244

Firm city

Redwood City

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy