Class 2 Device Recall RX ACCULINK Carotid Stent System

• Date Initiated by Firm: September 10, 2010
• Date Posted: November 10, 2010
• Recall Status: Terminated on November 16, 2010
• Recall Number: Z-0338-2011
• Recall Event ID: 56973
• PMA Number: P040012
• Product Classification: Stent, carotid - Product Code NIM
• Product: RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
• Code Information: Lot Number: 0072061
• Recalling Firm/ Manufacturer: Abbott Vascular; 26531 Ynez Rd; Temecula CA 92591-4630
• For Additional Information Contact: 951-914-2400
• Manufacturer Reason for Recall: The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
• FDA Determined Cause: Pending
• Action: Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter. The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular. For questions regarding this recall call (951) 914-3324.
• Quantity in Commerce: 42 units total for all products
• Distribution: Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI
• 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.

• PMA Database: PMAs with Product Code = NIM