Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
- Recall date
- December 20, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1026-2025
- FDA classification
- Class II
- Brand / firm
- Boston Scientific Corporation
- Sold / distributed
- Nationwide including Puerto Rico Foreign: To be provided
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
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