Boston Scientific Corporation recalls VersaCross Access Solution (VXSK)
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 00685447011729 Lots 35590858 35607785 35627540; VXSK0022
- UDI
- 00685447011736 Lots 35487923 35544014 35552652 35566071 35595443 35604160 35616857 VXSK0024
- UDI
- 00685447011750
- Lot #
- 35576278; VXSK0025
- UDI
- 00685447011767
- Lot #
- 35582041; VXSK0031
- UDI
- 00685447011828 Lots 35499536 35627156; VXSK0032
- UDI
- 00685447011835 Lots 35508294 35518904 35563958 35582043 35635451; VXSK0034
- UDI
- 00685447011859 Lots 35573519 35593310; VXSK0101
- UDI
- 00685447019749
- Lot #
- 35893570; VXSK0102
- UDI
- 00685447019756
- Lot #
- 35720571; VXSK0103
- UDI
- 00685447019763
- Lot #
- 36042383; VXSK0111
- UDI
- 00685447019794
- Lot #
- 35944186; VXSK0112
- UDI
- 00685447019800
- Lot #
- 36061050; VXSK0121
- UDI
- 00685447019817 Lots 35745702 35787463; VXSK0122
- UDI
- 00685447019824 Lots 35699501 35720572 35768613 35780309 35790937 35830237 35833400; VXSK0123
- UDI
- 00685447019831
- Lot #
- 35843757; VXSK0124
- UDI
- 00685447019848 Lots 35697863 35883199; VXSK0125
- UDI
- 00685447019855
- Lot #
- 35859706; VXSK0131
- UDI
- 00685447019862 Lots 35729751 35807530 35900608; VXSK0132
- UDI
- 00685447019879 Lots 35695371 35729750 35807531 35910367 35955008; VXSK0133
- UDI
- 00685447019886
- Lot #
- 35839894; VXSK0134
- UDI
- 00685447019893
- Lot #
- 35666909; VXSK0137
- UDI
- 00685447019909
- Lot #
- 35985522
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What the firm 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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2103-2025
- FDA 510(k) clearance · K150709The device's official FDA premarket clearance record
- FDA 510(k) clearance · K183655The device's official FDA premarket clearance record
- FDA device classification · DXFOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.5175The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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