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.
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.
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specific batches of Carotid WALLSTENT Monorail Endoprosthesis stents because some have greater resistance when being withdrawn from the guidewire or embolic protection device after deployment.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.
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.
Physicians who use these stents during carotid artery procedures are most at risk, particularly when removing the stent delivery system after successful stent deployment.
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.
Review the material numbers and batch numbers listed in the recall notice to determine if your stent is affected.
If your stent is affected, contact Boston Scientific directly for further instructions on how to handle the recalled stent.
Check the material numbers and batch numbers listed in the recall notice to see if your specific stent is affected.
Contact Boston Scientific directly for instructions on how to handle the recalled stent.
The recall does not specify that the stent should be stopped immediately; however, physicians should be cautious when removing the stent delivery system after deployment due to the risk of increased resistance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2273-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2273-2025 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.
