Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ev3 Recalled by Ev3, Inc. Due to Two production lots of the Protege Rx Tapered...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ev3, Inc. directly.
Affected Products
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, 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.
Quantity: 24
Why Was This Recalled?
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.
Where Was This Sold?
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
About Ev3, Inc.
Ev3, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report