VersaCross Transseptal Sheath VXS85-35-63-55-D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447003595), received between Apr 29, 2022 and Apr 29, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE (BAYLIS MEDICAL COMPANY INC.) WERE USED FOR THE INITIAL TRANSSEPTAL PUNCTURE OF THE PROCEDURE WITH NO OBSERVED INITIAL COMPLICATIONS. AFTER TRANSSEPTAL PUNCTURE, THE WATCHMAN FLX (BOSTON SCIENTIFIC CORP.) DEVICES WERE USED TO COMPLETE THE LAAC PROCEDURE. UPON POST-PROCEDURE VERIFICATION, THE PATIENT WAS NOTED TO HAVE A HEMOTHORAX. THE HEMOTHORAX WAS DRAINED AND THE PATIENT WAS KEPT FOR OBSERVATION. FOLLOW-UP REQUESTS REVELED THAT THE PATIENT IS DOING WELL AND IS EXPECTED TO RECOVER. AS THE HEMOTHROAX WAS IDENTIFIED AFTER COMPLETION OF THE CLOSURE PROCEDURE, THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS DEVICES WERE 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 REPORT NUMBER.

  Patient problems: Hemothorax

  MAUDE report 14249847 ↗