FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: 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) VXSK0122 VXSK (180P RF WIRE 63CM/55DEG/D0) VXSK0123 VXSK (180P RF WIRE 63CM/55DEG/D1) VXSK0124 VXSK (180P RF WIRE 63CM/90DEG/D0) VXSK0125 VXSK (230J RF WIRE 63CM/45DEG/D0) VXSK0111 VXSK (230J RF WIRE 63CM/45DEG/D1) VXSK0112 VXSK (230P RF WIRE 63CM/45DEG/D0) VXSK0131 VXSK (230P RF WIRE 63CM/45DEG/D1) VXSK0132 VXSK (230P RF WIRE 63CM/55DEG/D0) VXSK0133 VXSK (230P RF WIRE 63CM/55DEG/D1) VXSK0134 VXSK (230P RF WIRE 81CM/45DEG/D0) VXSK0137 VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0021 VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0022 VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0024 VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH VXSK0025 VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0031 VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0032 VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0034
- Recall number
- Z-2103-2025
- Recalling firm
- Boston Scientific Corporation
- 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) VXSK0122 VXSK (180P RF WIRE 63CM/55DEG/D0) VXSK0123 VXSK (180P RF WIRE 63CM/55DEG/D1) VXSK0124 VXSK (180P RF WIRE 63CM/90DEG/D0) VXSK0125 VXSK (230J RF WIRE 63CM/45DEG/D0) VXSK0111 VXSK (230J RF WIRE 63CM/45DEG/D1) VXSK0112 VXSK (230P RF WIRE 63CM/45DEG/D0) VXSK0131 VXSK (230P RF WIRE 63CM/45DEG/D1) VXSK0132 VXSK (230P RF WIRE 63CM/55DEG/D0) VXSK0133 VXSK (230P RF WIRE 63CM/55DEG/D1) VXSK0134 VXSK (230P RF WIRE 81CM/45DEG/D0) VXSK0137 VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0021 VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0022 VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0024 VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH VXSK0025 VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0031 VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0032 VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0034
- Status
- Open, Classified
- Initiated
- 2025-06-10
- Posted
- 2025-07-10
- Terminated
- not on file
- Reason
- Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Root cause
- Packaging change control
- Action
- On June 10, 2025, the firm began notifying consignees of the field action via Urgent Medical Device Removal letters. Customers are instructed to not use affected product. They should remove affected units from their inventory and segregate the units in a secure place until they can be returned to Boston Scientific.
- Quantity
- 14,724
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
- Lot, serial or model codes
- Product ID/UDI-DI/Batch Numbers: VXSK0021 UDI-DI 00685447011729 Lots 35590858 35607785 35627540; VXSK0022 UDI-DI 00685447011736 Lots 35487923 35544014 35552652 35566071 35595443 35604160 35616857 VXSK0024 UDI-DI 00685447011750 Lot 35576278; 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; VXSK0122 UDI-DI 00685447019824 Lots 35699501 35720572 35768613 35780309 35790937 35830237 35833400; 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
- 510(k) numbers
- ["K150709","K183655"]
- PMA numbers
- not on file
- Product code
- DXF
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28