Z-0188-2018Class II

Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in...

Name: Z-0188-2018 Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in...
Creator: Medtronic Inc.
Published: 2017-11-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-11-03 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or... on 2017-11-03. FDA classified it as Class II and gives the reason as "Stent length on the label may not match the length of the stent itself". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0188-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2017-11-29
Terminated: 2020-09-01
Recalling firm: Medtronic, Inc.
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.
Product code: NIP Stent, Superficial Femoral Artery
Reason for recall: Stent length on the label may not match the length of the stent itself.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0188-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-29

Product code NIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)