FDA-Device2017-12-06Class II
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
Medtronic Inc.
Hazard
Stent length on the label may not match the length of the stent itself.
Sold states
Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
Affected count
21 units
Manufactured in
4600 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2018Don't want to check this manually?
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