VersaCross transseptal sheath kits may have a punctured sterile barrier pouch
VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
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: Risk-of-harm product: a compromised sterile barrier on a cardiovascular access device, with no infection reported in the source.
Plain-English summary
The VersaCross Transseptal Sheath Kit (VXS), covering product IDs VXS0201 and VXS2112, used for the percutaneous introduction of various types of cardiovascular catheters, is being recalled. The action covers 14,724 units, lots 35800622 and 35892045.
According to the manufacturer, there is a potential for a hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. The manufacturer states the issue could potentially lead to systemic infection and sepsis in a worst case scenario, and that potential punctures may go undetected in clinical settings due to their small size and variable location. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States and to Canada and Hong Kong among other markets.
Facilities should identify affected stock using the product IDs, UDI-DI codes and lot numbers above and follow the instructions issued by the manufacturer.
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
- sterile-barrier
- tyvek-puncture
- infection-risk
- class-ii
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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