Versacross™ Access Solution, Torflex™ Transseptal Guiding Sheath And Versacross™ Transseptal Sheath

Recall Summary VersaCross Access Solution, TorFlex Transseptal Guiding Sheath, and VersaCross Transseptal Sheath are being recalled across Canada because they may not be sterile. These are medical devices used in cardiac procedures to access the heart. The recall affects all units distributed in Canada.

Product
VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
Reason
Sterility
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-06-19
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4b4029c1-ce88-4dfe-bd3c-cf6502d65b06