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Versacross™ access solution, torflex™ transseptal guiding sheath and versacross™ transseptal sheath
Official notice
19 Jun 2025
Last checked
19 Jun 2025
An official Health Canada notice concerns Versacross™ access solution, torflex™ transseptal guiding sheath and versacross™ transseptal sheath. 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 Published 2025-06-19.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77630
Official notice
2025-06-19
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Baylis Medical, Versacross™ Access Solution Torflex™ Transseptal Guiding Sheath And Versacross™ Transseptal Sheath.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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