Recall MonitorHealth Products
VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath and VersaCross™ Transseptal Sheath
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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