VersaCross™ Steerable Access Solution VSTK0118Recalls & 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 00685447019688), received between Jun 10, 2026 and Jun 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in 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
- Air/Gas in 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.
MalfunctionJun 10, 2026Air/Gas in Device
IT WAS REPORTED THAT VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED DURING THE PROCEDURE. IT HAS BEEN MENTIONED THAT THERE WAS RECURRING ISSUE WHERE THE PHYSICIAN VISUALIZED SIGNIFICANT AMOUNT OF AIR AND BUBBLES EVERY TIME THEY ATTEMPTED TO ASPIRATE AND INTRODUCE CATHETER THROUGH THE SHEATH. THIS SPECIFICALLY HAPPENS WHEN VERSACROSS SYSTEM WAS USED IN CONJUNCTION WITH A NON-BOSTON SCIENTIFIC MAPPING CATHETER. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25458158 ↗
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.