Transseptal Sheath Kit sterile barrier integrity issue with infection risk
Boston Scientific is recalling VersaCross Transseptal Sheath Kits due to potential holes in the sterile barrier pouch that could compromise device sterility and lead to infection or sepsis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a sterile barrier compromise that could potentially result in serious infection or sepsis. No hospitalizations or illnesses have been reported, making it a risk-of-harm scenario without documented injury.
Plain-English summary
Boston Scientific Corporation is recalling 14,724 units of the VersaCross Transseptal Sheath Kit (VXS), a medical device designed to introduce catheters and guidewires into the heart chambers during cardiac procedures. Two specific product codes are affected: VXS0201 (Lot 35800622) and VXS2112 (Lot 35892045).
The sterile barrier pouch of the affected devices may contain holes in the Tyvek layer, which could compromise device sterility. A compromised barrier poses a risk of pathogenic contamination, potentially leading to systemic infection and sepsis in patients—described as the worst-case scenario. Punctures may be difficult to detect in clinical settings because of their small size and variable location.
The affected devices have been distributed worldwide, including the United States, Canada, Hong Kong, and Japan.
The recalled product
- 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, includ
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sterility-compromise
- systemic-infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- VXS0201 UDI-DI 00685447020301 Lot 35800622
- VXS2112 UDI-DI 00685447019251 Lot 35892045
Distribution
Distributed nationwide across the United States.
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