Device product
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.
Z-0879-2015
Product summary
- Firm
- Ev3, Inc.
- Event
- Event 69965
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0879-2015
Official wording
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.
Code information: Lot # 9922795
Distribution pattern: International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Derived failure modes
-
Labeling or packaging
labeling error