FDAFDA · Food and drugs·Recall number Z-1030-2025
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Published February 5, 2025 · Recall initiated: December 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Nationwide including Puerto Rico Foreign: To be provided
- Lot
- GTIN: 08714729904625 Lot Numbers: 34477280
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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