Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-1028-2025)

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:

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: February 5, 2025

Recall Number: Z-1028-2025

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: 31 units

Code Information:

GTIN: 00191506008086 Lot Numbers: 33457806, 33512838, 34035520

Distribution Pattern:

Nationwide including Puerto Rico Foreign: To be provided

Voluntary or Mandated:

Voluntary: Firm initiated