—#159783

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.

FDA product code: NIP — Stent, Superficial Femoral Artery
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110023S012
Affected lot / code info: Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

Medtronic sent an Urgent Medical Device Recall letter on approximately 11/03/2017, via UPS 2-day delivery. Instructions include identify and quarantine all unused affected product in inventory, return all unused affected product, and complete and return the Customer Confirmation Certificate. Customers with questions regarding this communication, please contact your Medtronic Field Representative. For questions regarding this recall call 508-261-8000.

Recalling firm

Firm: Medtronic Inc.
Address: 4600 Nathan Ln N, Plymouth, Minnesota 55442-2890

Distribution

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

Timeline

Recall initiated: 2017-11-03
Terminated: 2020-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159783. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.