Boston Scientific recalls ELUVIA Drug-Eluting Vascular Stents due to incorrect packaging that may lead to stent misplacement during procedures. Affected units have specific lot numbers.
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Boston Scientific is recalling ELUVIA Drug-Eluting Vascular Stents because some units were packaged incorrectly, potentially causing stents to be placed in the wrong size. This could lead to improper treatment of blood vessels and complications during procedures.
The stents were incorrectly placed in 6x100mm packaging instead of 6x40mm. This could cause the stent to be too large for the blood vessel, leading to improper treatment or complications during procedures.
Patients who received the ELUVIA stent system with lot number 25838357 are affected. Medical professionals using this specific batch for procedures are at higher risk.
Check for the lot number 25838357 on the packaging. The ELUVIA stent system is used for treating blood vessels in the leg and is sold by Boston Scientific.
Look for the lot number 25838357 on the ELUVIA stent packaging.
Some stents were incorrectly placed in 6x100mm packaging instead of 6x40mm, which could lead to improper placement in blood vessels.
Check for the lot number 25838357 on the packaging. The ELUVIA stent system is used for treating blood vessels in the leg.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1621-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1621-2021 from Boston Scientific. 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.
