Axium Detachable Coil System Model Number: QC-2-2-3D recallZ-0841-2012 · Micro Therapeutics Inc, dba ev3 Neurovascular · initiated Nov 12, 2008
Terminated All recalls posted in January 2012
Is my device affected?
- 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.
- 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.
- 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 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.
FDA root cause category: Process control
What the company is doing
ev3 Neurovascular sent a "NOTIFICATION OF RECALL" letter dated November 6, 2008 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop use and segregate the affected product from inventory. A reply form was attached to the letter for customers to complete and fax to Customer Service at (763)398-7001. Customer Service will issue an RGA number for the return of the affected product. Contact the Quality Systems Manager at (949) 680-1305 for questions regarding this notice.
Recall details
- Recall number
- Z-0841-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 12, 2008
- Posted by the FDA
- Jan 24, 2012
- Recalling firm
- Micro Therapeutics Inc, dba ev3 Neurovascular
- Quantity
- 16
- Product code
- HCG
- FDA submissions
- K060747
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, CT, NE, NV, and WI. and the countries of Argentina, Brazil, Colombia, and Egypt.
Product description
Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.
Code information (models, lots, serial numbers)
Lot Number: 5871057
Other devices under the same FDA submission
1 device cleared under K060747 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Instant Detacher ID-1-5Micro Therapeutics, Inc. · Device, Vascular, for Promoting Embolization1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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