Recall Z-0878-2015— Ev3, Inc.
Class II · Terminated
Class II FDA medical device recall by Ev3, Inc., initiated 2014-12-04, terminated 2015-07-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Ev3, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-04
- Terminated
- 2015-07-17
- Firm location
- Plymouth, MN, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.