VersaCross Access Solution — Class II medical device recall Z-2103-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-07-16, distributed nationwide. Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Iss
| Recall number | Z-2103-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2025-06-10 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, JP |
| Quantity | 14,724 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00685447011729, 00685447011736, 00685447011750, 00685447011767, 00685447011828, 00685447011835, 00685447011859, 00685447019749, 00685447019756, 00685447019763, 00685447019794, 00685447019800, 00685447019817, 00685447019824, 00685447019831, 00685447019848, 00685447019855, 00685447019862, 00685447019879, 00685447019886, 00685447019893, 00685447019909 |
| Lot numbers | 35487923, 35499536, 35508294, 35518904, 35544014, 35552652, 35563958, 35566071, 35573519, 35576278, 35582041, 35582043, 35590858, 35593310, 35595443, 35604160, 35607785, 35616857, 35627156, 35627540, 35635451, 35666909, 35695371, 35697863, 35699501, 35720571, 35720572, 35729750, 35729751, 35745702, 35768613, 35780309, 35787463, 35790937, 35807530, 35807531, 35830237, 35833400, 35839894, 35843757 and 32 more |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2103-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.