Z-0873-2012

Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the...

Name: Z-0873-2012 Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the...
Creator: Micro Therapeutics Inc, dba ev3 Neurovascular
Published: 2010-03-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-03-01 / Terminated / root cause: manufacturing process

FDA source

Micro Therapeutics Inc, dba ev3 Neurovascular began a recall of Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and... on 2010-03-01. The reason FDA records is "ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0873-2012
Status: Terminated
Initiated: 2010-03-01
Posted: 2012-01-26
Terminated: 2012-01-31
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: HCG Device, Neurovascular Embolization
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.
Root cause tag: manufacturing process
FDA 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 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 commerce: 13 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.
Product codes and lots: Lot # 7964576

Product code HCG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)