Medtronic Inc. recalls Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treat…

Recall date

November 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0188-2018

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA

Why it was recalled

Stent length on the label may not match the length of the stent itself.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.