medical Class I Updated 2026-02-11

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery-Enhanced Delivery System - 8m

Recalled Product

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

Hazard / Issue

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 the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043,

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