Class 2 Device Recall Micrus

• Date Initiated by Firm: September 08, 2006
• Date Posted: September 29, 2006
• Recall Status: Terminated on June 29, 2007
• Recall Number: Z-1542-06
• Recall Event ID: 36344
• 510(K)Number: K053265
• Product Classification: Guide wire soft tip - Product Code DQX
• Product: Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA
• Code Information: All lots including F22741, F22742, F22743, F22744, F22745, F22746, F22747, F22749.
• FEI Number: 3003079393
• Recalling Firm/ Manufacturer: Micrus Endovascular Corporation; 821 Fox Lane; San Jose CA 95131
• For Additional Information Contact: Khashi Yavari; 408-433-1460
• Manufacturer Reason for Recall: During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.
• FDA Determined Cause: Other
• Action: On 9/8/06 the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
• Quantity in Commerce: 413 units
• Distribution: Worldwide
• 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 = DQX