Boston Scientific Corporation 2025-02-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1030-2025
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 Recall
Issued February 5, 2025 · Boston Scientific Corporation
In February 2025, Boston Scientific Corporation recalled the AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- February 5, 2025
- Units affected
- Not reported
- Sold at
- Nationwide including Puerto Rico Foreign: To be provided
- Recall number
- FDA-Z-1030-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.