FDA recall Z-0188-2018

Medtronic Inc. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-11-03
Report date
2017-12-06
Termination date
2020-09-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2018