FDA-Device2012-10-03Class II
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
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.
Sold states
Nationwide(US) Distribution and Puerto Rico.
Affected count
61,799 units
Manufactured in
26531 Ynez Rd, N/A, Temecula, CA, United States
Products
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2012Don't want to check this manually?
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