Arstasis One Access System Recalled Because Components may Fracture Leading to Patient Harm

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The FDA warns Cardiologists and Risk Managers that Arstasis One Access System is recalled because its components may fracture and/or separate resulting in patient harm.

Background of Arstasis One Access System

The Arstasis One Access System, by Arstasis Inc., provides device access into the vascular system of patients that undergo diagnostic femoral artery (upper leg) catheterization procedures. In conjunction with manual compression it helps to stop bleeding.

FDA Alert on Arstasis One Access System

FDA’s reason for the recall is that Arstasis One Access System components may fracture and/or separate during use and this can lead to patient harm.

The affected models are:  AAD100, AAD101, the affected part numbers are: FG-02279, FG-03010 and the affected lot numbers are:  09I10268, 1OC26337, 09J06281, 10C12334.

The distribution dates were from May 14, 2010 to October 13, 2010.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Arstasis One Access System

“Customers should work with their local Arstasis territory manager to ensure product replacement.”

Contacting the FDA to report cases with Arstasis One Access System

In case of detection of adverse events or side effects related to the use of Arstasis One Access System, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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