Back to RecallTracker
Health Canada Medical devices

VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath

Issued June 19, 2025
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. Recall start date: June 10, 2025
Hazard description
Sterility
Product
Product name
VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
Reference
ID
RA-77630