Class 3 Device Recall AngioSeal

• Date Initiated by Firm: June 07, 2006
• Date Posted: November 07, 2006
• Recall Status: Terminated on November 13, 2006
• Recall Number: Z-0157-2007
• Recall Event ID: 35819
• PMA Number: P930038S040
• Product Classification: Vascular Closure Device - Product Code MGB
• Product: The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
• Code Information: Lot 1204437
• Recalling Firm/ Manufacturer: St. Jude Medical / Daig Division; 14901 Deveau Pl; Minnetonka MN 55345-2126
• Manufacturer Reason for Recall: The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
• FDA Determined Cause: Other
• Action: All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
• Quantity in Commerce: 4,770 Units
• Distribution: Nationwide.
• 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 = MGB