FDAHealthJune 10, 2025
Boston Scientific Corporation — VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the perc
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 10, 2025
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
What's affected?
- Product
- 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.
- Lot code
- 35800622
Additional details
VXS0201 UDI-DI 00685447020301 Lot 35800622; VXS2112 UDI-DI 00685447019251 Lot 35892045
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,724.
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