VersaCross™ Steerable Access Solution VSTK0124Recalls & reported problems
Boston Scientific Corporation · Steerable Access Solution · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447019732), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION A RF WIRE WAS SELECTED FOR USE. IT IS BELIEVED THAT THE TRANSEPTAL WIRE PERFORATED IN OR AROUND THE LAA DURING EXCHANGE. A PERICARDIAL TAP WAS PERFORMED TO PULL BLOOD FROM THE SPACE AND STABILIZE THE PATIENT. THE PROCEDURE WAS CANCELLED AT THIS TIME AND THE PATIENT IS EXPECTED TO FULLY RECOVER.
Patient problems: Cardiac Perforation; Perforation
MAUDE report 24935261 ↗
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.