Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-1034-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: February 5, 2025

Recall Number: Z-1034-2025

Event ID: 96049

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.

Status: Ongoing

Product Quantity: 519 units (OUS)

Code Information:

GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098

Distribution Pattern:

Nationwide including Puerto Rico Foreign: To be provided

Voluntary or Mandated:

Voluntary: Firm initiated