Micro Therapeutics Axium Detachable Coil System Recall: Incorrect Labeling Risk
Micro Therapeutics recalls two Axium Detachable Coil System models due to incorrect size and configuration labeling, which may lead to improper use. Affected units include QC-4-12-HELIX and QC-10-30-3D with specific lot numbers.
Lower-risk recall
Due to incorrect size and configuration labeling of the detachable coil system.
Contact the company
What happened, in plain English
Micro Therapeutics is recalling two specific models of detachable coil systems because their size and configuration labels are incorrect. This could lead to improper use if the coils are not properly matched to the intended medical device. Read more at govinfonow.com/recall/60757-micro-therapeutics-axium-detachable-coil-system-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60757-micro-therapeutics-axium-detachable-coil-system-recall-incorrect-labeling-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1261-2022
Cite this page
“Micro Therapeutics Axium Detachable Coil System Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60757-micro-therapeutics-axium-detachable-coil-system-recall-incorrect-labeling-risk. Based on FDA recall #Z-1261-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1261-2022%22&limit=1).
Why it’s dangerous
The incorrect labeling means the coil system might not fit correctly with the intended medical device. This could lead to improper use during procedures, potentially causing complications if the coils are not properly matched.
Who’s affected
Patients using these specific medical coil systems for procedures are likely affected. Those with the incorrect labeling may face improper use if the coils are not properly matched to the intended device.
How to tell if you have this one
Check for product numbers QC-4-12-HELIX or QC-10-30-3D. The lot numbers B240079 and B240084 are also associated with these models.
- Brand
Micro Therapeutics- Category
Medical device
What to do — step by step
Check Product Label
Look for the product number and lot number on the device to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1261-2022 (April 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1261-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.