Back to search
Published: 2026-02-11Captured: 2026-02-20Boston Scientific CorporationProduct: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
FDA issued a Class I enforcement action. Affects Boston Scientific Corporation. Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting fro.
- •Classification: Class I
- •Firm: Boston Scientific Corporation
- •Status: Ongoing
- •Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Braz...
Reason
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange...
Status:Ongoing
Distribution
Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Ge...
View Sourcee94d67c0…