Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-1027-2025)

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 15mmx15mm UPN: M00553670

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: February 5, 2025

Recall Number: Z-1027-2025

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: 309 units

Code Information:

GTIN: 08714729979333 Lot Numbers: 32901294, 33223930, 33328461, 33413626, 33459702, 33686175, 33686176, 33766912, 33814306, 33825089, 33860266, 33920983, 33920984, 33930917, 34020982, 34020983, 34111459, 34111480, 34111481, 34135618, 34135619, 34136372, 34271635, 34297652, 34316296

Distribution Pattern:

Nationwide including Puerto Rico Foreign: To be provided

Voluntary or Mandated:

Voluntary: Firm initiated