VersaCross RF Wire VXW-35-230-P-WMRecalls & reported problems
Boston Scientific Corporation · 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00685447011118), received between Jan 6, 2023 and Jan 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection 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 18, 2026.
Most reported problems
Device problems
- Connection Problem1
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.
MalfunctionJan 6, 2023Connection Problem; Connection Problem
A 20-MINUTE PROCEDURAL WAS REPORTED FOR THE VERSACROSS RF WIRE KIT (CONTAINING THE VERSACROSS RF WIRE AND AN RFP-100A CONNECTOR CABLE (CONNECTOR CABLE)) WHERE THE CONNECTOR CABLE WAS NOT ABLE TO ESTABLISH A CONNECTION WHEN CONNECTED TO THE VERSACROSS RF WIRE AND COMPATIBLE RF GENERATOR DURING A LEFT-ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. WHILE ATTEMPTING TO COMPLETE THE TRANSSEPTAL PUNCTURE, THE VERSACROSS WIRE WAS POSITIONED ON THE SEPTUM AND WAS THEN CONNECTED TO THE GENERATOR THROUGH THE CONNECTOR CABLE. HOWEVER, THE GENERATOR DID NOT RECOGNIZE THAT THE DEVICE WAS CONNECTED. THE CONNECTOR CABLE WAS DISCONNECTED AND RECONNECTED, HOWEVER, THE GENERATOR STILL DID NOT DETECT THE DEVICE. THE GROUNDING PAD THAT WAS CONNECTED TO THE GENERATOR WAS ALSO SWAPPED OUT AND THE GENERATOR WAS REPLACED WITH A SECOND GENERATOR. HOWEVER, THE ISSUE CONTINUED TO PERSIST. AN NRG TRANSSEPTAL NEEDLE AND CONNECTOR CABLE (BAYLIS MEDICAL COMPANY INC.) WERE OPENED AND CONNECTED TO THE FIRST GENERATOR AND THE TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16117816 ↗
Other Catheter, Septostomy devices
- VersaCross Access Solution VXSK0031Baylis Médicale Cie Inc · Catheter, Septostomy1 recall16 reports
- VersaCross Access Solution VXSK0021Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 death15 reports
- VersaCross Access Solution VXSK0032Baylis Médicale Cie Inc · Catheter, Septostomy1 recall14 reports
- VersaCross Access Solution VXSK0022Baylis Médicale Cie Inc · Catheter, Septostomy1 recall13 reports
- VersaCross Access Solution VXSK0024Baylis Médicale Cie Inc · Catheter, Septostomy1 recall3 reports
- VersaCross Access Solution VXSK0025Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 report
- VersaCross Access Solution VXSK0034Baylis Médicale Cie Inc · Catheter, Septostomy1 recall1 report
- NRG Transseptal Needle NRG-E-HF-71-C0Boston Scientific Corporation · Catheter, Septostomy22 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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