FDA Enforcement
Class II
Terminated
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.
Recall: Z-0878-2015
·
Reported January 7, 2015
Enforcement
- Recall Number
- Z-0878-2015
- Event ID
- 69965
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ev3, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 7, 2015
- Initiation Date
- December 4, 2014
- Classification Date
- December 29, 2014
- Termination Date
- July 17, 2015
- Address
- 4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States
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
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 Info
Lot # 9922452
Distribution
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Quantity
14