Boston Scientific Corporation recalls VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHE…

Recall date

June 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2105-2025

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.