Class 2 Device Recall StarClose

• Date Initiated by Firm: January 31, 2007
• Date Posted: March 08, 2007
• Recall Status: Terminated on February 26, 2008
• Recall Number: Z-0575-2007
• Recall Event ID: 37270
• 510(K)Number: K060902
• Product Classification: Vascular Closure System - Product Code DYB
• Product: StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063
• Code Information: Lot Numbers starting from 43034-6H to 47139-6H
• Recalling Firm/ Manufacturer: Abbott Vascular, Inc.; 400 Saginaw Dr; Redwood City CA 94063-4749
• For Additional Information Contact: Denise Singleton; 650-474-3193
• Manufacturer Reason for Recall: Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
• FDA Determined Cause: Other
• Action: On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep.
• Quantity in Commerce: 97,952 units
• Distribution: Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
• 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.

• 510(K) Database: 510(K)s with Product Code = DYB