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Abbott Vascular recalls Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Recalled October 3, 2012 · FDA recall Z-2450-2012 · Abbott Vascular
Hazard
Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating. · FDA Class II
Units
61,799 units
Sold at
Nationwide(US) Distribution and Puerto Rico.
Description
Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
Product
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Manufacturer(s)
Abbott Vascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →