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Terminated

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 Recall Z-0188-2018 · Posted None

Recalling FirmMedtronic Inc.
Recall StatusTerminated
Product CodeNIP
Date Initiated2017-11-03
Date Terminated2020-09-01
Product Quantity21 units

Reason for Recall

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

Firm Action

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.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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