Ev3, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0878-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 4, 2014

Date Posted: January 7, 2015

Recall Number: Z-0878-2015

Event ID: 69965

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.

Status: Terminated

Product Quantity: 14

Code Information:

Lot # 9922452

Distribution Pattern:

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

Voluntary or Mandated:

Voluntary: Firm initiated