AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1025-2025.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1025-2025.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Boston Scientific Corporation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1025-2025.
Boston Scientific Corporation
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Boston Scientific Corporation Recall FAQ
Boston Scientific Corporation is the subject of a medical implants safety report: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650. The notice was published on December 20, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 1,144 units are potentially affected.