Boston Scientific VersaCross Guide Wire Sterile Barrier Defect
Boston Scientific is recalling VersaCross Access Solution guide wires due to potential holes in the sterile barrier pouch that may compromise device sterility and could lead to systemic infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a theoretical hazard. No illnesses or injuries are reported in the source. Per the rubric, a risk-of-harm product with no reported injuries receives a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of VersaCross Access Solution (VXSK) guide wires. The recalled products include radiofrequency guide wires in multiple configurations.
The recall is due to a potential defect in the Tyvek layer of the sterile barrier pouch. Small holes may potentially develop in this protective layer, which could compromise the device's sterility. These defects may go undetected in clinical settings due to their small size and variable location.
Approximately 14,724 units have been distributed worldwide, including to the United States, Canada, Hong Kong, and Japan. If the sterile barrier is compromised, the device could become contaminated, potentially leading to systemic infection and sepsis.
Healthcare facilities should immediately stop using the recalled lots and verify their inventory using the product identification numbers and lot information provided by the manufacturer. Patients who have received these devices should contact their healthcare provider if they develop signs of infection.
The recalled product
- Product
- VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Guide Wire
- Hazard
- sterile-barrier-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- VXSK0025 UDI-DI 00685447011767 Lot 35582041
- VXSK0031 UDI-DI 00685447011828 Lots 35499536 35627156
- VXSK0032 UDI-DI 00685447011835 Lots 35508294 35518904 35563958 35582043 35635451
- VXSK0034 UDI-DI 00685447011859 Lots 35573519 35593310
- VXSK0101 UDI-DI 00685447019749 Lot 35893570
- VXSK0102 UDI-DI 00685447019756 Lot 35720571
- VXSK0103 UDI-DI 00685447019763 Lot 36042383
- VXSK0111 UDI-DI 00685447019794 Lot 35944186
- VXSK0112 UDI-DI 00685447019800 Lot 36061050
- VXSK0121 UDI-DI 00685447019817 Lots 35745702 35787463
- VXSK0123 UDI-DI 00685447019831 Lot 35843757
- VXSK0124 UDI-DI 00685447019848 Lots 35697863 35883199
- VXSK0125 UDI-DI 00685447019855 Lot 35859706
- VXSK0131 UDI-DI 00685447019862 Lots 35729751 35807530 35900608
- VXSK0132 UDI-DI 00685447019879 Lots 35695371 35729750 35807531 35910367 35955008
- VXSK0133 UDI-DI 00685447019886 Lot 35839894
- VXSK0134 UDI-DI 00685447019893 Lot 35666909
- VXSK0137 UDI-DI 00685447019909 Lot 35985522
Distribution
Distributed nationwide across the United States.
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