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.
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
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.
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.
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.
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.
Identify the lot number and model to confirm if your stent is affected.
The recall specifies that in some regions, this stent is indicated for renal arteries, but the recall applies to specific models and lot numbers.
The recall record does not specify a remedy, so contact Atrium Medical directly for guidance.
The hazard involves potential loss of balloon pressure during deployment, which could lead to complications, but the recall does not specify a risk of serious injury.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0291-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0291-2024 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
