Axios recallZ-1159-2026 · Boston Scientific Corporation · initiated Dec 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
FDA root cause category: Process control
What the company is doing
On December 19, 2025, Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: - Immediately stop further distribution or use of any remaining affected devices. Remove them from your facility s inventory and segregate them in a secure location until they can be returned to Boston Scientific. " Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. " Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. " If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. " Boston Scientific reminds healthcare professionals that AXIOS Stents should only be used as indicated in Instructions For Use.
Recall details
- Recall number
- Z-1159-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2025
- Posted by the FDA
- Feb 5, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 39 units
- Product code
- KNS
- FDA submissions
- K233318
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.
Product description
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Code information (models, lots, serial numbers)
Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Axios™ M00553680Boston Scientific Corporation · Pancreatic stent, covered, metallic, removable2 recalls20 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98237).
- Z-1158-2026 · Open, ClassifiedAXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
- Z-1160-2026 · Open, ClassifiedAXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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