VersaCross™ Access Solution VXSK0125Recalls & reported problems
Boston Scientific Corporation · Access Solution · Class 2
All models of VersaCross Access Solution (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jun 10, 2025Open, Classified
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.
Z-2103-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
Other Percutaneous atrial catheter kit devices
- VersaCross Connect Access Solution for FARADRIVE VXAK0041Boston Scientific Corporation · Percutaneous Atrial Catheter Kit3 deaths275 reports
- VersaCross Connect™ LAAC Access Solution VXAK0107Boston Scientific Corporation · Percutaneous atrial catheter kit3 deaths77 reports
- VersaCross™ Access Solution VXSK0122Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall2 deaths21 reports
- VersaCross™ Access Solution VXSK0131Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall2 deaths12 reports
- VersaCross™ Access Solution VXSK0132Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall11 reports
- VersaCross™ Access Solution VXSK0134Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall1 death11 reports
- VersaCross™ Access Solution VXSK0121Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall6 reports
- VersaCross™ Access Solution VXSK0124Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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