Medtronic Inc.: Medical Device Recall in 2017 - (Recall #: Z-0188-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 3, 2017

Date Posted: December 6, 2017

Recall Number: Z-0188-2018

Event ID: 78570

Reason for Recall:

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

Status: Terminated

Product Quantity: 21 units

Code Information:

Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated