VersaCross™ Large Access Solution VLAK0109Recalls & reported problems
Boston Scientific Corporation · Large 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 00685447019565), received between Mar 20, 2026 and Mar 20, 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 Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
DURING A FARAWATCH PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE AND VERSACROSS LARGE ACCESS SOLUTION WAS SELECTED FOR USE. A SMALL PERICARDIAL EFFUSION WAS NOTED AT BASELINE ON ICE. ABLATION HAD JUST BEGUN, AND WHILE CONFIRMING CATHETER CONTACT ON ICE IN THE LEFT SUPERIOR PULMONARY VEIN, A LARGER AND GROWING EFFUSION WAS OBSERVED. NO RESISTANCE WAS FELT WHILE MANEUVERING ANY CATHETERS. DESPITE THE ENLARGING EFFUSION, THE PHYSICIAN ELECTED TO CONTINUE THE PROCEDURE TO COMPLETE BOTH THE ABLATION AND THE WATCHMAN IMPLANT. A PERICARDIOCENTESIS WAS PERFORMED AT THE END OF THE CASE, AND 900 ML OF BLOOD WAS REMOVED. THE LOCATION OF A PERFORATION WAS NOT CONFIRMED, AND NO IMAGING IDENTIFYING A PERFORATION SITE WAS AVAILABLE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE COMPLICATION. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS RETAINED BY THE ACCOUNT.
Patient problems: Cardiac Tamponade; Pericardial Effusion
MAUDE report 24650601 ↗
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.