Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Micrus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Micrus see related information
Date Initiated by Firm September 08, 2006
Date Posted September 29, 2006
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = MICRUS ENDOVASCULAR CORPORATION
-
-