VersaCross Connect Access Solution for FARADRIVE VXAK0047Recalls & reported problems
Boston Scientific Corporation · 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)) · Class 2
All models of VersaCross Connect Access Solution for FARADRIVE (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00685447019077), received between Jul 10, 2025 and Jul 10, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stroke/CVA1
- Thrombosis/Thrombus1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED STROKE. DURING A FARAPULSE ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE WAS SELECTED FOR USE. ACCESS WAS PERFORMED FOR INSERTION OF AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND A FARADRIVE SHEATH. FIRST THE PHYSICIAN DECIDED TO ABLATE THE CTI LINE WITH FARAPULSE, AND THEN THE PHYSICIAN USED THE GRID MAPPING CATHETER ON THE CTI LINE. NEXT, THE PHYSICIAN ATTEMPTED TO MAP THE CTI LINE WITH THE GRID CATHETER. IT WAS AT THIS TIME THAT THIS AFS CLINICAL NOTICED THERE WAS THROMBUS ON THE GRID MAPPING CATHETER ON ICE. THE PHYSICIAN ASPIRATED THE SHEATH AND RE-SHEATHED THE GRID AND REMOVED IT FROM THE BODY. THE GRID WAS THEN PULLED OUT, AND THE SHEATH WAS FLUSHED FOLLOWING ASPIRATION WITH A 20CC SYRINGE. THEN, THE VERSACROSS FARADRIVE CONNECT WAS INTRODUCED, AND TRANSEPTAL PUNCTURE WAS SUCCESSFULLY PERFORMED. THE PHYSICIAN PERFORMED THE ABLATIONS ON EACH VEIN WITHOUT INCIDENT. THE EXACT NUMBER OF APPLICATIONS WITH THE FARAPULSE ARE IN THE REPORT. THE PHYSICIAN BELIEVES THAT THERE MAY HAVE BEEN AN EMBOLIC EVENT FOLLOWING TRANSEPTAL FROM THE CLOT THAT WAS PRESENT AFTER CTI LINE APPLICATION AND MAPPING WITH THE GRID. THE PHYS
Patient problems: Stroke/CVA; Thrombosis/Thrombus; Visual Disturbances
MAUDE report 22471909 ↗
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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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