Axios recallZ-1030-2025 · Boston Scientific Corporation · initiated Dec 20, 2024
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
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
FDA root cause category: Process control
What the company is doing
Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. 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. Contact your local Boston Scientific representative with any questions.
Recall details
- Recall number
- Z-1030-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 20, 2024
- Posted by the FDA
- Jan 29, 2025
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 12 units
- Product code
- KNS
- FDA submissions
- K181905
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
Product description
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Code information (models, lots, serial numbers)
GTIN: 08714729904625 Lot Numbers: 34477280
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Axios™ M00553740Boston Scientific Corporation · pancreatic stent, covered, metallic, removable1 recall2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96049).
- Z-1024-2025 · Open, ClassifiedAXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
- Z-1025-2025 · Open, ClassifiedAXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
- Z-1026-2025 · Open, ClassifiedAXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
- Z-1027-2025 · Open, ClassifiedAXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
- Z-1028-2025 · Open, ClassifiedAXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
- Z-1029-2025 · Open, ClassifiedAXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
- Z-1031-2025 · Open, ClassifiedAXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
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.
How recalls are matched to devices · Editorial policy · Report an error on this page