Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular emboli

FDA device recall Z-0874-2012 · posted 2012-01-26 · Terminated

Recall details

Recalling firm

Micro Therapeutics Inc, dba ev3 Neurovascular

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.

Action taken

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 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.

Root cause

Employee error

Status

Terminated

Product code

KRD

Quantity affected

14 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.

Date initiated

2010-03-01

Date posted

2012-01-26

Date terminated

2012-01-31

Location

Irvine, CA

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