VersaCross Large Access Transseptal Dilator VLA125-35-67-D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447005254), received between Nov 12, 2021 and Jul 6, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF A PERICARDIAL EFFUSION REQUIRING INTERVENTION WAS REPORTED DURING A LEFT-ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, WHERE THE VERSACROSS LARGE ACCESS TRANSEPTAL DILATOR (VLA) WAS USED FOR THE INITIAL TRANSSEPTAL PUNCTURE. THE VLA WAS POSITIONED IN THE SUPERIOR VENA CAVA (SVC) USING THE J-TIP GUIDEWIRE. THE PHYSICIAN EXCHANGED THE J-TIP GUIDEWIRE WITH THE VERSACROSS RF WIRE (VXW) FOR TRANSSEPTAL PUNCTURE. WHILE REMOVING THE J-TIP GUIDEWIRE, THE VLA SLIPPED OUT OF THE SVC INTO THE RIGHT ATRIUM (RA) AS IT WAS NOT SECURED AND WAS REPOSITIONED. THE VXW WAS ADVANCED AND TRANSSEPTAL WAS SUCCESSFULLY COMPLETED. THE VLA WAS REMOVED AND WATCHMAN SHEATH (BOSTON SCIENTIFIC) WAS ADVANCED. THE VXW WAS EXCHANGED WITH THE J-TIP GUIDEWIRE AND A PIGTAIL CATHETER WAS INTRODUCED OVER THE J-TIP GUIDEWIRE IN THE LEFT ATRIAL APPENDAGE (LAA). DYE WAS RELEASED AND FLUID AROUND THE LAA WAS NOTED. A PERICARDIAL SWEEP WAS PERFORMED AND AN EFFUSION WAS NOTED. THE EFFUSION CONTINUED TO WORSEN. WITH THE PATIENT IN STABLE CONDITION, PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO SURGERY APPROXIMATELY 30 MINUTES LATER. A 8.5-9 FRENCH HOLE WAS IDENTIFIED IN THE MEDIAL ASPECT OF THE SVC A

  Patient problems: Pericardial Effusion

  MAUDE report 14940179 ↗
• MalfunctionJan 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  A PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR (VLA) WAS USED IN A TRANSSEPTAL PROCEDURE. A 0.035 J TIP GUIDEWIRE WAS PLACED IN THE SUPERIOR VENA CAVA (SVC), FOLLOWED BY ADVANCEMENT OF THE VLA OVER THE GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO TRACK UP TO THE SVC, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN HAD DIFFICULTY MANEUVERING THE DEVICES AND THE GUIDEWIRE WAS DAMAGED WHILE IT WAS BEING PULLED BACK INTO THE VLA. THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY AND THE TRANSSEPTAL ACCESS WAS COMPLETED SUCCESSFULLY USING THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE. THERE WAS NO PATIENT INJURY REPORTED. HOWEVER, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY THAT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237738 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF CARDIAC TAMPONADE OCCURRED DURING A CRYOABLATION PROCEDURE, WHERE THE VERSACROSS RF WIRE AND VERSACROSS LARGE ACCESS DILATOR WERE USED ALONG OTHER DEVICES. THE RIGHT ATRIAL WALL WAS PUNCTURED INADVERTENTLY WHILE ATTEMPTING TRANSSEPTAL PUNCTURE MULTIPLE TIMES DUE TO POOR IMAGING WITH THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. THE PATIENT DEVELOPED AN EFFUSION LEADING TO CARDIAC TAMPONADE. CHEST COMPRESSION AND CPR WAS PERFORMED, FOLLOWED BY PERICARDIOCENTESIS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS CONDUCTED TO CHECK FOR CARDIAC STRUCTURES. THERE WAS NO LEFT OR RIGHT ATRIAL COMPRESSION NOTED . THE PROCEDURE WAS ABORTED AFTER APPROXIMATELY 2-HOUR DELAY. THE PATIENT WAS ANNOUNCED TO BE IN A STABLE CONDITION; HOWEVER, HYPOXIA WAS NOTED. THE PATIENT STARTED CRASHING AGAIN. CHEST COMPRESSION AND CPR WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS A BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE VERSACROSS RF WIRE WITH MDR REPORT NUMBER 9710

  Patient problems: Cardiac Tamponade

  MAUDE report 12803609 ↗