Recall of Surgical Medical Device

Components of the Arstasis One Access System, a device that provides access into the vascular system and can stop an artery from bleeding, may fracture and/or separate during use, which may result in patient harm.

AUDIENCE: Cardiology, Risk Manager

ISSUE: Components of the Arstasis One Access System may fracture and/or separate during use, which may result in patient harm. The following products are affected by this recall: Models: AAD100, AAD101; Part Numbers: FG-02279, FG-03010; Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334. These products were distributed from May 14, 2010 through October 13, 2010.

BACKGROUND: 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.

RECOMMENDATION: Customers should work with their local Arstasis territory manager to ensure product replacement.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-017