Boston Scientific Carotid WALLSTENT Stent Recall: Risk of Stroke During Removal
Boston Scientific recalls certain Carotid WALLSTENT Monorail Endoprosthesis stents due to increased resistance when removing the stent delivery system, which could cause stroke or vessel injury during procedure.
Use caution until it’s fixed
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
Contact the company
What happened, in plain English
Boston Scientific is recalling specific batches of Carotid WALLSTENT Monorail Endoprosthesis stents because some have greater resistance when being withdrawn from the guidewire or embolic protection device after deployment. This could lead to stroke, vessel injury, or other complications during the procedure. Read more at govinfonow.com/recall/51838-boston-scientific-carotid-wallstent-stent-recall-risk-of-stroke-during.
Source Summary by GovInfoNow · govinfonow.com/recall/51838-boston-scientific-carotid-wallstent-stent-recall-risk-of-stroke-during · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2273-2025
Cite this page
“Boston Scientific Carotid WALLSTENT Stent Recall: Risk of Stroke During Removal.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51838-boston-scientific-carotid-wallstent-stent-recall-risk-of-stroke-during. Based on FDA recall #Z-2273-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2273-2025%22&limit=1).
Why it’s dangerous
The stent material in certain batches creates higher resistance when the stent delivery system (SDS) is pulled back from the guidewire or embolic protection device (EPD) after stent deployment. This can cause the SDS to get stuck, potentially leading to stroke, vessel injury, vessel spasm, or requiring additional intervention.
Who’s affected
Physicians who use these stents during carotid artery procedures are most at risk, particularly when removing the stent delivery system after successful stent deployment.
How to tell if you have this one
Check the material numbers listed in the recall notice: H7493915010240, H7493915010310, H749391506220, H749391508210, H749391508290, H965SCH647010, H965SCH647070, H965SCH647080, H965SCH647090, H965SCH647120, H965SCH647130, H965SCH647140, M001719000, M001719010, M001719020, M001719030, M001719040, M001719050, M001719060. Also check the batch numbers listed for each material.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Your Stent Model
Review the material numbers and batch numbers listed in the recall notice to determine if your stent is affected.
Contact Boston Scientific
If your stent is affected, contact Boston Scientific directly for further instructions on how to handle the recalled stent.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
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-2273-2025 (July 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2273-2025 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.