Invatec Llc recalls lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec

Recalled June 12, 2013 · FDA recall Z-1517-2013 · Invatec

Hazard

Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified. · FDA Class II

Units

177 units

Sold at

Nationwide Distribution

Description

Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

Product

lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Manufacturer(s)

Invatec Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →