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U.S. Department of Health and Human Services

Class 2 Device Recall XACT Carotid Stent System

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  Class 2 Device Recall XACT Carotid Stent System see related information
Date Initiated by Firm March 19, 2009
Date Posted March 16, 2010
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-1153-2010
Recall Event ID 53477
Product Classification Stent, carotid - Product Code NIM
Product Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01)

The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
Code Information Lot Number: 9020551 
Recalling Firm/
Manufacturer		 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer Reason
for Recall		 Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.
FDA Determined
Cause 2		 PMA
Action Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site.
Quantity in Commerce 49
Distribution Nationwide: GA, NY, IN, LA, MA and PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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