AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

FDA Recall #Z-1026-2025 — Class II — December 20, 2024

Recall #Z-1026-2025 Date: December 20, 2024 Classification: Class II Status: Ongoing

Product Description

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

1399 units; 20 units (OUS)

Distribution

Nationwide including Puerto Rico Foreign: To be provided

Code Information

GTIN: 08714729951179 Lot Numbers: 32913258, 32914587, 32914588, 32914951, 32919344, 33161778, 33167722, 33167723, 33167724, 33168696, 33168697, 33217106, 33217107, 33223926, 33223927, 33224949, 33233462, 33234152, 33235720, 33235721, 33242497, 33242560, 33324868, 33333642, 33577901, 33577905, 33661063, 33677043, 33677044, 33677045, 33677046, 33677047, 33677048, 33680523, 33697485, 33767880, 33776935, 33776936, 33778737, 33778738, 33785758, 33785759, 33787022, 33787023, 33787024, 33787025, 33796610, 33804642, 34034896, 34034897, 34034898, 34037953, 34037954, 34037955, 34038584, 34038795, 34047362, 34047364, 34047365, 34074520, 34074521, 34093768, 34093769, 34101923, 34101924, 34126523, 34126524, 34128158, 34130337, 34134859, 34135080, 34136360, 33333648, 33470460, 33488331, 33509930, 33509931, 33509936, 33509937, 33510694, 33510695, 33517861, 33517862, 33568702, 33568703, 33571498, 33577559, 33577900, 33827339, 33883094, 33899654, 33902104, 33902106, 33908817, 33908818, 33908819, 33930901, 33931714, 33939630, 33998884, 33998885, 34004996, 34006717, 34027241, 34142867, 34144887, 34161824, 34161826, 34165830, 34165831, 34172977, 34172979, 34262100, 34307464, 34344894, 34356855, 34364514, 34772813

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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