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

Recalled December 6, 2017 · FDA recall Z-0188-2018 · Medtronic

Hazard

Stent length on the label may not match the length of the stent itself. · FDA Class II

Units

21 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Medtronic Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →