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Class 2 Device Recall Everflex SelfExpanding Peripheral Stent with Entrust Delivery System |
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Date Initiated by Firm |
November 03, 2017 |
Create Date |
November 29, 2017 |
Recall Status1 |
Terminated 3 on September 01, 2020 |
Recall Number |
Z-0188-2018 |
Recall Event ID |
78570 |
PMA Number |
P110023S012 |
Product Classification |
Stent, superficial femoral artery - Product Code NIP
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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. |
Code Information |
Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301. |
Recalling Firm/ Manufacturer |
Medtronic Inc. 4600 Nathan Ln N Plymouth MN 55442-2890
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For Additional Information Contact |
Krystin Hayward 508-261-8000
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Manufacturer Reason for Recall |
Stent length on the label may not match the length of the stent itself.
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FDA Determined Cause 2 |
Employee error |
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. |
Quantity in Commerce |
21 units |
Distribution |
Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = NIP and Original Applicant = MEDTRONIC VASCULAR INC
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