FDA-Device2025-07-16Class II
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.
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Affected count
14,724
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2025Don't want to check this manually?
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