VersaCross RF Wire VXW-35-180-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00685447003298), received between Oct 20, 2021 and Jan 6, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, THE VERSACROSS RF WIRE USED DURING TRANSSEPTAL SHEARED OFF. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118767 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF AORTIC PERFORATION LEADING TO PROCEDURAL ABORTION WAS REPORTED WHERE THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE WERE USED FOR TRANSSEPTAL PUNCTURE. TRANSSEPTAL PUNCTURE WAS COMPLETED SUCCESSFULLY TWICE. HOWEVER, THE LOCATION OF THE PUNCTURE WAS NOT OPTIMAL FOR IMPLANTATION OF THE WATCHMAN DEVICE. ON THE THIRD ATTEMPT, THE VERSACROSS RF WIRE AND VERSACROSS TRANSSPETAL SHEATH CROSSED THE SEPTUM SUCCESSFULLY AND ADVANCED INTO THE LEFT ATRIUM WHERE A PERFORATION OCCURRED. AN EFFUSION WAS ALSO NOTED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND WAS TREATED WITH PERICARDIOCENTESIS. THE PHYSICIAN CONSULTED SURGERY AND THE PROCEDURE WAS ABORTED. AS A BAYLIS MEDICAL DEVICE WAS 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 TRANSSEPTAL SHEATH WITH THE REPORT NUMBER 3019751610-2022-00030.

  Patient problems: Perforation

  MAUDE report 15337611 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF A BLOOD CLOT FORMATION REQUIRING INTERVENTION WAS REPORTED DURING A CRYOABLATION PROCEDURE WHERE THE BAYLIS MEDICAL VERSACROSS RF WIRE (RF WIRE), AND VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR WERE USED FOR INITIAL TRANSSEPTAL PUNCTURE. TRANSSPETAL PUNCTURE WAS SUCCESSFULLY COMPLETED AND THE VERSACROSS LARGE ACCESS DILATOR WAS REMOVED FROM THE PATIENT. THE RF WIRE REMAINED IN THE LEFT ATRIUM OF THE PATIENT MAINTAINING TRANSSEPTAL ACCESS. AFTER ABOUT 10 MINUTES POST TRANSSEPTAL, HEPARIN WAS ADMINISTERED. WHILE ADVANCING THE CRYOABLATION SHEATH INTO THE LEFT ATRIUM OVER THE RF WIRE USING AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER, A BLOOD CLOT ON THE RF WIRE WAS NOTED. AN INTERVENTIONAL CARDIOLOGIST WAS CONSULTED. DURING DEPLOYMENT OF A SENTINEL CEREBRAL PROTECTION SYSTEM (BOSTON SCIENTIFIC), THE RF WIRE WAS INADVERTENTLY PULLED BACK DISPLACING THE BLOOD CLOT FROM THE RF WIRE. VASCULAR SURGERY AND NEURO-INTERVENTION WERE CONSULTED. THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN. CT RESULTS WERE NORMAL. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14596407 ↗
• MalfunctionApr 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A 20-MINUTE PROCEDURAL DELAY WAS REPORTED DUE TO KNOTTING OF THE VERSACROSS RF WIRE (RF WIRE) WHILE ATTEMPTING TO PULL THE WIRE INTO THE VERSACROSS TRANSSEPTAL SHEATH FOR THE DROP DOWN OF THE TRANSSEPTAL PUNCTURE WORKFLOW. THE VERSACROSS TRANSSEPTAL SHEATH BECAME KINKED IN THE PROCESS. THE PROCEDURE WAS ABLE TO CONTINUE AFTER A NEW VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL SHEATH WERE USED TO PERFORM A SUCCESSFUL TRANSSEPTAL PUNCTURE. 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 14106901 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF AORTIC PERFORATION LEADING TO A PROCEDURAL ABORTION WAS REPORTED DURING A CRYOABLATION ATRIAL FIBRILLATION PROCEDURE, WHERE THE VERSACROSS RF WIRE WAS USED TO ATTEMPT TRANSSEPTAL PUNCTURE. DUE TO COMPLEX PATIENT ANATOMY, THE PHYSICIAN ATTEMPTED A MORE SUPERIOR TRANSSEPTAL APPROACH, AND WHILE ADVANCING THE RF WIRE, THE PHYSICIAN NOTICED AN ARTIFACT AND MANEUVERED AN ICE CATHETER TO INVESTIGATE. UPON INVESTIGATION, THE RF WIRE WAS OBSERVED TO BE IN THE AORTA. THE PHYSICIAN IMMEDIATELY REQUESTED A SURGICAL CONSULT, AFTER WHICH THE RF WIRE WAS REMOVED FROM THE AORTA WITHOUT FURTHER COMPLICATIONS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ADMITTED TO THE ICU FOR OVERNIGHT OBSERVATION WHERE THEY WERE LATER SENT HOME.

  Patient problems: Perforation

  MAUDE report 13739460 ↗
• 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 LARGE ACCESS TRANSSEPTAL DILATOR WI

  Patient problems: Cardiac Tamponade

  MAUDE report 12803643 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION WAS REPORTED IN A PROCEDURE WHERE THE VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL SHEATH WERE USED AMONG OTHER DEVICES, INCLUDING THE CRYO SHEATH CATHETER. INTRA-CARDIAC ECHOCARDIOGRAPH CONFIRMED THERE WAS AN EFFUSION, AFTER BAYLIS MEDICAL PRODUCTS HAD BEEN REMOVED FROM THE PATIENT. PERICARDIOCENTESIS WAS PERFORMED BUT THE EFFUSION PERSISTED SO THE DOCTOR TRANSFERRED THE PATIENT TO SURGERY. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. THERE IS NO SUSPECTED DEVICE FAILURE. A SEPARATE MDR HAS BEEN SUBMITTED FOR THE VERSACROSS TRANSSEPTAL SHEATH UNDER MFR REPORT NUMBER: 9710452-2021-00046

  Patient problems: Pericardial Effusion

  MAUDE report 12664499 ↗