A product used in patients undergoing diagnostic catheterization procedures is being recalled because the device may fracture and/or separate during use, which may result in patient harm. The recall includes certain model and lots of the Arstasis One Access System, and falls into the Food and Drug Administration (FDA) Class 1 recall category, which is the most serious type of recall and involves situations in which there is a reasonable probability of serious adverse health consequences or death.

The Artasis One Access System is used in patients undergoing diagnostic femoral artery, or upper leg, cauterization procedures, and also provides access into the vascular system. The product also helps stop the artery from bleeding when used in conjunction with manual compression.

The recall includes model numbers AAD100 and AAD101; part numbers FG-02279 and FG-03010; and lot numbers 09I10268, 1OC26337, 09J06281, and 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.

Customers of Artasis have been sent letters explaining that all existing devices will be replaced. Health care professionals and consumers are encouraged to report any adverse reactions, side effects, or quality problems they experience while using these or any other medical products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.FDA.gov/Medwatch.