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Axium Detachable Coil System QC-2-1-Helix recallZ-0873-2012 · Micro Therapeutics Inc, dba ev3 Neurovascular · initiated Mar 1, 2010

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Micro Therapeutics Inc, dba ev3 Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-0873-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 1, 2010
Posted by the FDA
Jan 26, 2012
Recalling firm
Micro Therapeutics Inc, dba ev3 Neurovascular
Quantity
13 units
Product code
HCG
FDA submissions
K060747, K081465
Distribution
Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.

Product description

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.

Code information (models, lots, serial numbers)

Lot # 7964576

Other devices under the same FDA submission

233 devices cleared under K060747, K081465 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 55696).

Sources and updates

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