Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-2104-2025)

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:

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

Product Classification:

Class II

Date Initiated: June 10, 2025

Date Posted: July 16, 2025

Recall Number: Z-2104-2025

Event ID: 97036

Reason for Recall:

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

Status: Ongoing

Product Quantity: 14,724

Code Information:

UDI-DI 00685447006121 Lot 35935598

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated