Summary
Product
VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
Issue
Medical devices – Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Issue
Boston Scientific is initiating a removal of specific lots of the VersaCross Access Solution, TorFlex Transseptal Guiding Sheath, and VersaCross Transseptal Sheath due to the potential for a hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.