Z-2048-2016Class II

EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only...

Name: Z-2048-2016 EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only...
Creator: Ev3, Inc.
Published: 2016-05-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-05-23 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc. began a recall of EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding... on 2016-05-23. FDA classified it as Class II and gives the reason as "Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2048-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Posted: 2016-06-23
Terminated: 2017-09-22
Recalling firm: Medtronic, Inc.
Product: EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
Product code: NIP Stent, Superficial Femoral Artery
Reason for recall: Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Medtronic sent an "Urgent Medical Device Recall" letter dated May 2016, to all affected customers. The letter described the problem and the product involved in the recall. Consignees were instructed to identify, quarantine and return unused product to Medtronic. Consignees were requested to complete the Customer Confirmation Certificate and email it to RS.CFQFCAMedtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Customers with questions were instructed to call 651-367-0612. For question regarding this recall call 763-398-7000.
Quantity in commerce: 2
Distribution: Nationwide Distribution to LA and WI.
Product codes and lots: lot: A164580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2048-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2048-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-23

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)