VersaCross™ Steerable Access Solution VSTK0104Recalls & reported problems
Boston Scientific Corporation · Steerable Access Solution · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447019626), received between Mar 12, 2026 and Mar 12, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Nonstandard Device
DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT AN ATRIAL FLUTTER AND ATRIAL FIBRILLATION, THERE APPEARED TO BE A TORN OR DAMAGED SHEATH TIP AS SEEN ON THE VERY DISTAL END OF THE BLUE MATERIAL OF THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578446 ↗
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 VXSK0134Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall1 death11 reports
- VersaCross™ Access Solution VXSK0132Boston Scientific Corporation · Percutaneous atrial catheter kit1 recall11 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.