Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-1032-2025)

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 6mmx8mm UPN: M00553520

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: February 5, 2025

Recall Number: Z-1032-2025

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: 263 units (OUS)

Code Information:

GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272

Distribution Pattern:

Nationwide including Puerto Rico Foreign: To be provided

Voluntary or Mandated:

Voluntary: Firm initiated