VersaCross Connect Access Solution for FARADRIVE VXAK0043Recalls & 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 00685447019053), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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. 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
- Human-Device Interface Problem1
Patient problems
- Heart Block1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT THE PATIENT WENT INTO AV BLOCK. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE KIT WAS SELECTED FOR USE. DURING PLACEMENT OF THE FARADRIVE AND CONNECT ON THE FOSSA OVALIS, THE SHEATH SLIPPED ANTERIOR. THE PHYSICIAN CLICKED THE SHEATH AND DILATOR BACK TO THE SEPTUM AND THE PATIENT WENT INTO EXTENDED AV BLOCK. THEN, THE CORONARY SINUS CATHETER WAS MOVED TO THE VENTRICLE TO PACE DURING PROCEDURE. THE PACING RATE SLOWLY REDUCED UNTIL INTRINSIC RHYTHM CAME BACK. DURING THE SECOND ATTEMPT TO PLACE THE SHEATH AND DILATOR, THE PATIENT WENT INTO AV BLOCK AGAIN. THE PHYSICIAN BELIEVES, THIS IS IS DUE TO THE SHEATH BEING SO LARGE THAT IT WANTS TO FALL ANTERIOR AND THE DILATOR SO STIFF THAT IT IS TRAUMATIC. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY GO TRANSEPTAL USING THIS PRODUCT. THE PATIENT WAS IN 2:1 BLOCK FOR THE MAJORITY OF THE PROCEDURE, BUT THEIR AV NODE RECOVERED BY THE CASE END. THE PATIENT MIGHT BE KEPT OVERNIGHT FOR OBSERVATION. THE PATIENT MIGHT BE REFERRED FOR A PACEMAKER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IN THE PHYSICIAN'S OPINION, THE SIZE AND FORM OF THE VERSACROSS CONNECT FITTED INTO THE FARA
Patient problems: Heart Block
MAUDE report 20578098 ↗
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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