Arstasis One Access System components may fracture and/or separate, FDA warns

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The FDA announced on 9 February 2011 that components of the Arstasis One Access System may fracture and/or separate during use, which may result in patient harm. This system is used in patients undergoing diagnostic femoral artery (upper leg) catheterisation procedures. It provides device access into the vascular system and helps to stop the artery from bleeding when used in conjunction with manual compression.

The FDA recommends physicians to contact Arstasis to ensure product replacement. The products affected by this recall were distributed from 14 May 2010 through 13 October 2010 and correspond to the models: AAD100, AAD10; part numbers: FG-02279, FG-03010; lot numbers: 09I10268, 1OC26337, 09J06281, 10C12334.

 

The Arstasis One Access System received FDA clearance in May 2010, and started the RECITAL (A Patient Registry Evaluating Closure Following Access with the Arstasis One Access System) study in November 2010, a non-randomised, prospective, post-approval study with 500 patients in seven US hospitals.   The system was nationwide launched in the United States in January 2011.

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