Z-0878-2015Class II

ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the...

Name: Z-0878-2015 ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the...
Creator: Ev3, Inc.
Published: 2014-12-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-12-04 / Terminated / root cause: packaging

FDA source

Ev3, Inc. began a recall of ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events... on 2014-12-04. FDA classified it as Class II and gives the reason as "Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0878-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Posted: 2014-12-29
Terminated: 2015-07-17
Recalling firm: Medtronic, Inc.
Product: ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Product code: NIM Stent, Carotid
Reason for recall: Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
Quantity in commerce: 14
Distribution: International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Product codes and lots: Lot # 9922452

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0878-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0878-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-29
Z-0879-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-29

Product code NIM

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)