FDAClass IIDecember 6, 2017

Everflex Self-Expanding Peripheral Stent with Entrust recall

Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or…

Why was Everflex Self-Expanding Peripheral Stent with Entrust recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or…
Recalling firm
Medtronic Inc.
Quantity
21 units
Distribution
Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
Recall date
December 6, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls