HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Recall #Z-1036-2025 — Class II — December 20, 2024
Product Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Reason for Recall
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.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1102 units (OUS)
Distribution
Nationwide including Puerto Rico Foreign: To be provided
Code Information
GTIN: 08714729951100 Lot Numbers: 32865866, 32874910, 32875944, 32876867, 32876869, 32876870, 33195387, 33195388, 33195389, 33195390, 33209841, 33209843, 33215357, 33283337, 33284518, 33284519, 33288532, 33288534, 33301346, 33301347, 33301348, 33301351, 33301352, 33466658, 33467021, 33470461, 33470464, 33470465, 33486865, 33487939, 33519203, 33528652, 33581298, 33581681, 33601247, 33657824, 33686163, 33686166, 33765267, 33804643, 33806748, 33909812, 33909813, 33920980, 33948082, 33977789, 33981155, 33981156, 34006718, 34015882, 34020432, 34020433, 34020434, 34027240, 34047363, 34065574, 34074522, 34076577, 34083205, 34085563, 34101925, 34102569, 34102570, 34102571, 34103179, 34103340, 34111453, 34111454, 34111456, 34111845, 34116472, 34116473, 34126522, 34180835, 34190940, 34190949, 34201914, 34205933, 34205934, 34213826, 34214585, 34214586, 34223572, 34223574, 34325972, 34325974, 34334692, 34335366, 34371087, 34371088, 34371090, 34523681, 34545213, 34649321, 34815303
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated