CLASS II ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report

VersaCross Access Solution (Vxsk), Product Description recalled

Boston Scientific is recalling VersaCross Access Solution (Vxsk), Product Description and ID: Vxsk (180J RF, distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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

Quantity recalled14,724

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2103-2025
FDA event ID: 97036
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jun 2025
FDA classified: 10 Jul 2025
Reported: 16 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Other Medical Devices

Timeline

10 Jun 2025	Recall initiated by company
10 Jul 2025	Classified by FDA	+30 days
16 Jul 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 97036

This product is part of a recall event; the main page for the event is Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific.

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025	CLASS II	Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
16 Jul 2025	CLASS II	VersaCross RF Wire (VXW) recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
16 Jul 2025	CLASS II	VersaCross Transseptal Sheath Kit recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide

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