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VersaCross Access Solution (VXSK) recallZ-2103-2025 · Boston Scientific Corporation · initiated Jun 10, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging change control

What the company is doing

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.

Recall details

Recall number
Z-2103-2025
Status
Open, Classified
Initiated by the company
Jun 10, 2025
Posted by the FDA
Jul 10, 2025
Recalling firm
Boston Scientific Corporation
Quantity
14,724
Product code
DXF
FDA submissions
K150709, K183655
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

22 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97036).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page