VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0031 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0122 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0137 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0034 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0123 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0132 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0133 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0102 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0131 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0022 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0024 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0121 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0125 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0134 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0021 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0025 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0032 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0124 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0101 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0103 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0111 |
VersaCross™ Access Solution |
More than 10 numbers, contact manufacturer. |
VXSK0112 |
TorFlex™ Transseptal Guiding Sheath |
35644132 |
TF85-32-63-45 |
TorFlex™ Transseptal Guiding Sheath |
35508747 |
TF85-32-63-45 |
TorFlex™ Transseptal Guiding Sheath |
35746496 |
TF85-32-63-45 |
TorFlex™ Transseptal Guiding Sheath |
35913449 |
TF85-32-63-45 |
TorFlex™ Transseptal Guiding Sheath |
35738145 |
TF85-32-63-55 |
TorFlex™ Transseptal Guiding Sheath |
35508748 |
TF85-32-63-55 |
VersaCross™ Transseptal Sheath |
35800622 |
VXS0201 |
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
Additional information
Details
Baylis Medical Company Inc.
5959 Trans-Canada Highway, Montreal, Quebec, Canada, H4T 1A1
Get notified
Receive emails about new and updated recall and safety alerts.