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.
This recall has been terminated (originally issued November 3, 2017).
- Company
- Medtronic Inc.
- Recall Initiated
- November 3, 2017
- Terminated
- September 1, 2020
- Recall Number
- Z-0188-2018
- Quantity
- 21 units
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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
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.
Root Cause
Employee error
Action Taken
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.