Recall record at a glance
| Official record | Z-2103-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Boston Scientific Corporation |
| Report date | Jul 16, 2025 |
| Recall initiation date | Jun 10, 2025 |
| Quantity | 14,724 |
| Location | Saint Paul, MN, United States |
Official 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
Why the product 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.
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: N/A.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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