Recall Z-0873-2012 ยท HCG Device, Neurovascular Embolization
Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System QC-2-1-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.
| Date | Jan 26, 2012 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production. |
| Root cause | Employee error |
| Action | Micro 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 a |
| Quantity | 13 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of the UK, and France. |
| FDA record | Open on fda.gov |