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U.S. Department of Health and Human Services

Medical Devices

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Arstasis One Access System

Recall Class: Class I

Date Recall Initiated: October 19, 2010

Product: Arstasis One Access System

Models: AAD100, AAD101

Part Numbers: FG-02279, FG-03010

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

The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features.

These products were distributed from May 14, 2010 through October 13, 2010.

Use: The Arstasis One Access System is used in patients undergoing diagnostic femoral artery (upper leg) catheterization procedures. It provides device access into the vascular system. This product also helps to stop the artery from bleeding when used in conjunction with manual compression.

Recalling Firm:
Arstasis, Inc.
740 Bay Road
Redwood City, California 94063-2469

Reason for Recall: Components of this device may fracture and/or separate during use, which may result in patient harm.

Public Contact:

Customers with questions or concerns can contact Customer Service at 1-877-594-4545.

FDA District: San Francisco

FDA Comments:

On October 19, 2010, the company sent its customers a recall letter informing them that they are improving their product. The company will replace all existing devices with the improved product in their customers’ inventory that have not yet been used.

Customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily. Customers are to complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service by FAX at 1-877-688-8417 or by email to customerservice@arstasis.com.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.