Boston Scientific ELUVIA Stent Recall: Incorrect Packaging May Cause Misplacement
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.
Recall notice
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62759-boston-scientific-eluvia-stent-recall-incorrect-packaging-may-cause-misplacement.
Source Summary by GovInfoNow · govinfonow.com/recall/62759-boston-scientific-eluvia-stent-recall-incorrect-packaging-may-cause-misplacement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1621-2021
Cite this page
“Boston Scientific ELUVIA Stent Recall: Incorrect Packaging May Cause Misplacement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62759-boston-scientific-eluvia-stent-recall-incorrect-packaging-may-cause-misplacement. Based on FDA recall #Z-1621-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Packaging
Look for the lot number 25838357 on the ELUVIA stent packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
FDA distribution: “US Nationwide distribution in the states of AL, AR, AZ, CA, DE, HI, IL, KS, KY, MA, MD, NC, NJ, NV, NY, OH, OK, PA,PR, TX, VA,WA,WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Delaware, Hawaii, Illinois, Kansas, Kentucky, Maryland, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-1621-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1621-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.