FDA-Device2013-10-16Class I
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.
Bard Peripheral Vascular Inc
Hazard
Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.
Sold states
US Nationwide Distribution.
Affected count
4112 units
Manufactured in
1625 W 3rd St Ste 109, N/A, Tempe, AZ, United States
Products
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2014Don't want to check this manually?
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