Z-0878-2015 Class II Terminated
FDA device recall Z-0878-2015 was initiated by Ev3, Inc. on December 4, 2014 and is designated Class II. 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. The recall status is terminated (terminated July 17, 2015). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- January 7, 2015
- Initiation Date
- December 4, 2014
- Termination Date
- July 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
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.
Distribution Pattern
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Code Information
Lot # 9922452