VersaCross Connect Transseptal Dilator VXA12-85-35-WM-D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447010531), received between Sep 29, 2022 and Oct 11, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF THROMBUS FORMATION WAS REPORTED DURING AN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WHERE THE VERSACROSS CONNECT TRANSSEPTAL DILATOR (VXA) WAS USED FOR THE TRANSSEPTAL PUNCTURE. WHILE POSITIONING THE VXA AND WATCHMAN ACCESS SHEATH (BOSTON SCIENTIFIC) ON THE SEPTUM, A THROMBUS FORMATION AT THE DISTAL END OF THE VXA WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING. THE DEVICES WERE REMOVED AND FLUSHED, NO THROMBUS WAS NOTED ON ANY DEVICE OR ON IMAGING. THE DEVICES WERE REINSERTED AND THE TRANSEPTAL PUNCTURE AND SUBSEQUENT LAAC PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15581927 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BLOOD CLOT WAS OBSERVED ON THE VERSACROSS RF WIRE (RF WIRE) USED FOR TRANSSEPTAL PUNCTURE DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. HEPARIN WAS ADMINISTERED AND TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED WITH THE RF WIRE. ADDITIONAL HEPARIN WAS ADMINISTERED. SUBSEQUENTLY, A CLOT WAS NOTED ON THE TIP OF THE RF WIRE. THE VERSACROSS CONNECT TRANSSEPTAL DILATOR (VXA DILATOR) AND WATCHMAN ACCESS SHEATH (BOSTON SCIENTIFIC) USED WITH THE RF WIRE WERE ADVANCED THROUGH THE SEPTUM INTO THE LEFT ATRIUM. THE VXA DILATOR WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN ASPIRATED THE CLOT ON THE RF WIRE. AFTER THE CLOT WAS NO LONGER VISUALIZED, THE WATCHMAN ACCESS SHEATH WAS REMOVED AND FLUSHED. THE VXA DILATOR AND WATCHMAN ACCESS SHEATH WERE RE-INSERTED. AFTER SEPTAL DILATION, THE VXA DILATOR WAS REMOVED WITH THE WATCHMAN ACCESS SHEATH REMAINING IN PATIENT TO PROCEED WITH THE LAAC PROCEDURE. ANOTHER CLOT WAS OBSERVED ON THE WATCHMAN ACCESS SHEATH VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. THE CLOT WAS ASPIRATED. THE LAAC PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS NOTED POST PROCEDURE. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15508475 ↗