Boston Scientific Corporation
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →