Official recall record
VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-06-19
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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