Official recall record
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DE
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-06-10
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00685447011729
- Brand on record
- Boston Scientific Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-06 · US FDA — Medical Devices
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 72 - 2026-08-06 · US FDA — Medical Devices
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 726 - 2026-08-06 · US FDA — Medical Devices
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 724
All 92 official recall notices naming Boston Scientific Corporation on this site →
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