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U.S. Department of Health and Human Services

Class 3 Device Recall Axium Detachable Coil System QC730Helix

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 Class 3 Device Recall Axium Detachable Coil System QC730Helixsee related information
Date Initiated by FirmMarch 01, 2010
Date PostedJanuary 26, 2012
Recall Status1 Terminated 3 on January 31, 2012
Recall NumberZ-0874-2012
Recall Event ID 55696
510(K)NumberK081465 
Product Classification Device, neurovascular embolization - Product Code KRD
ProductAxium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.
Code Information Lot # 7964590
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 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.
FDA Determined
Cause 2		Employee error
ActionMicro Therapeutics Inc, dba ev3 Neurovascular performed product recovery according to the following outline. a) Quality Assurance Department (QAD) was used to provide details of product distribution for the affected lots. b) Based on the Health Hazard Assessment, the risk was considered undesirable. c) The affected product was part of a limited market release for Physician Preference Testing. As the product was within control of ev3 employees, no public notification was performed. d) Quality Systems contacted the sales representatives identifying the part number, lot number and number of units sent, and a request to segregate and return the affected product was initiated. e) Product returned to ev3 Neurovascular was held in Restricted Stock pending complete device accountability and disposition. f) The ev3 Neurovascular Quality Assurance department scrapped the affected product. g) The ev3 Neurovascular Regulatory Affairs department was responsible for assuring documentation and appropriate notification to regulatory bodies as required.
Quantity in Commerce14 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of the UK, and France.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRD
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