VersaCross Transseptal Sheath VXS85-35-63-45-D0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00685447003380), received between Feb 13, 2020 and Apr 23, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT VERSACROSS TRANSSEPTAL SHEATH WAS SELECTED FOR USE. DURING OPENING, IT WAS REALIZED THE TAP HANDLE WAS BROKEN AND RENDERING THE SHEATH UNUSABLE. THE PROCEDURE WAS COMPLETED BY USING DIFFERENT DEVICE DIFFERENT MODEL. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966153 ↗
• MalfunctionOct 1, 2024Break; Material Perforation; Break; Material Perforation

  IT HAS BEEN REPORTED THAT AN BMC TRANSSEPTAL SHEATH WAS SELECTED FOR ABLATION. DURING PREPARATION, THE SIDE PORT OF THE STOPCOCK BROKE OFF AT THE CONNECTION TO THE TUBING. THUS, A NEW BMC TRANSSEPTAL SHEATH WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT RETURNING FOR ANALYSIS (DISPOSED). NO OTHER ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347311 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION REQUIRING INTERVENTION WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, WHERE THE BAYLIS MEDICAL, VERSACROSS STEERABLE SHEATH (VST), VERSACROSS TRANSSEPTAL SHEATH (VXS) AND VERSACROSS RF WIRE (VXW) WERE USED FOR THE INITIAL TRANSSEPTAL PUNCTURE. THE VST WAS WIRED WITH THE VXW AND INSERTED IN THE PATIENT. DUE TO COMPLEX PATIENT ANATOMY, THE PHYSICIAN EXPERIENCED DIFFICULTY MANEUVERING THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE TO VISUALIZE TENTING OF THE SEPTUM. THE PHYSICIAN ATTEMPTED TO REWIRE AND RE-POSITION THE VST ON THE SEPTUM SIX MORE TIMES. TENTING OF THE SEPTUM COULD NOT BE CONFIRMED DUE TO POOR IMAGING AND THE VST WAS EXCHANGED WITH THE VXS. THE VXS WAS SHAPED, WIRED AND INSERTED FOR POSITIONING. WITH NO CLEAR IMAGING OF THE SEPTUM OR THE VXS, THE PHYSICIAN REQUESTED ANOTHER SIZED SHEATH. BEFORE THE SHEATH COULD BE EXCHANGED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A PERFORATION LEADING TO PERICARDIAL EFFUSION WAS NOTED IN THE RIGHT ATRIAL APPENDAGE. THE LAAC PROCEDURE WAS ABORTED. PERICARDIOCENTESIS WAS PERFORMED. CARDIOTHORACIC SURGERY WAS CONSULTED. MORE FLUID WAS REMOVED AND THE PATIENT WAS STABILIZED. THERE

  Patient problems: Pericardial Effusion

  MAUDE report 14597530 ↗
• InjuryApr 16, 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 MITRACLIP PROCEDURE WHERE THE VERSACROSS TRANSSEPTAL SHEATH AND THE VERSACROSS RF WIRE WERE USED AMONG OTHER DEVICES INCLUDING THE SUPRACORE WIRE (ABBOTT). A 3MM CUT WAS LOCATED BETWEEN THE RIGHT ATRIUM AND THE SUPERIOR VENA CAVA. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE EFFUSION AND THE PROCEDURE WAS ABORTED. 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 THE REPORT NUMBER 9710452-2021-0024.

  Patient problems: Pericardial Effusion

  MAUDE report 11679553 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE VERSACROSS RF WIRE WAS USED FOR TRANSSEPTAL PUNCTURE AND ANCHORED IN THE LEFT ATRIUM (LA). THE PHYSICIAN ATTEMPTED TO DILATE THE SEPTUM WITH THE VERSACROSS TRANSSEPTAL SHEATH AND DILATOR, FOLLOWED BY AN EVERCROSS DILATION CATHETER. PERICARDIAL EFFUSION OCCURRED DURING THE SEPTUM DILATION. DUE TO THE PERICARDIAL EFFUSION, THE CASE WAS ABORTED. A PERICARDIAL TAP WAS PERFORMED AND THE PATIENT WAS SENT TO RECOVERY. TORTUOUS ANATOMY WAS A CONTRIBUTING FACTOR TO OCCURRENCE OF THE EFFUSION. THERE IS NO EVIDENCE TO SUGGEST THAT A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICE WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Pericardial Effusion

  MAUDE report 9708194 ↗