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U.S. Department of Health and Human Services

Class 3 Device Recall The AXIUM DETACHABLE COIL SYSTEM

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  Class 3 Device Recall The AXIUM DETACHABLE COIL SYSTEM see related information
Date Initiated by Firm November 12, 2008
Date Posted January 24, 2012
Recall Status1 Terminated 3 on January 26, 2012
Recall Number Z-0841-2012
Recall Event ID 50776
510(K)Number K060747  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Axium Detachable Coil System Model Number: QC-2-2-3D.

The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.
Code Information Lot Number: 5871057
Recalling Firm/
Manufacturer		 Micro Therapeutics Inc, dba ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact
949-839-3700
Manufacturer Reason
for Recall		 ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.
FDA Determined
Cause 2		 Process control
Action ev3 Neurovascular sent a "NOTIFICATION OF RECALL" letter dated November 6, 2008 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop use and segregate the affected product from inventory. A reply form was attached to the letter for customers to complete and fax to Customer Service at (763)398-7001. Customer Service will issue an RGA number for the return of the affected product. Contact the Quality Systems Manager at (949) 680-1305 for questions regarding this notice.
Quantity in Commerce 16
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, CT, NE, NV, and WI. and the countries of Argentina, Brazil, Colombia, and Egypt.
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 = HCG and Original Applicant = MICRO THERAPEUTICS, INC.
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