Atrium Advanta V12 Stent Recall: Balloon-Catheter Weld Failure Risk
Atrium Medical recalls V12 covered stents for potential balloon-catheter weld failure during renal artery procedures. Affected units include specific sizes and lot numbers. Contact for remedy.
Use caution until it’s fixed
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Contact the company
What happened, in plain English
Atrium Medical is recalling a specific stent model due to a risk that the balloon and catheter may not seal properly during deployment, potentially causing loss of pressure. This could lead to complications in treating renal arteries. Read more at govinfonow.com/recall/57294-atrium-advanta-v12-stent-recall-balloon-catheter-weld-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/57294-atrium-advanta-v12-stent-recall-balloon-catheter-weld-failure-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0291-2024
Cite this page
“Atrium Advanta V12 Stent Recall: Balloon-Catheter Weld Failure Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57294-atrium-advanta-v12-stent-recall-balloon-catheter-weld-failure-risk. Based on FDA recall #Z-0291-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0291-2024%22&limit=1).
Why it’s dangerous
The stent's balloon may fail to seal with the catheter during deployment, causing loss of pressure. This could lead to improper stent placement or complications in renal artery treatments.
Who’s affected
Patients undergoing renal artery procedures with the specific stent model and lot numbers are most at risk. Healthcare providers using the recalled stent system should check their inventory.
How to tell if you have this one
Check for the model 'Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm' and lot numbers 464909 or 464910. The product is indicated for renal arteries in some regions but not all.
- Brand
Atrium Medical- Category
Medical device
What to do — step by step
Check Product Details
Identify the lot number and model to confirm if your stent is affected.
How this recall unfolded
Recall timeline
FDA published this recall 2 months 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-0291-2024 (September 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0291-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.