VersaCross Steerable Access Solution VSTK0021Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00685447012122), received between Jul 12, 2023 and Jun 25, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A VERSACROSS STEERABLE KIT WAS SELECTED FOR USE. THE PATIENT HAD A VERY THICK SEPTUM CAUSING DIFFICULTY TO CROSS FOR TRANSSEPTAL ACCESS. INITIALLY, THERE WERE THREE ATTEMPTS TO CROSS THE SEPTUM MADE BY THE PHYSICIAN AND THEN ANOTHER PHYSICIAN AS CONSULTED. AT THIS TIME, THEY CHOSE TO INCREASE THE RADIO FREQUENCY (RF) DELIVERY OF THE VERSACROSS RF WIRE FROM 1 TO 2 SECONDS/CONSTANT TO ACCOMMODATE FOR THE THICK SEPTUM. THE FOURTH ATTEMPT WAS THEN SUCCESSFUL. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE HOWEVER LATER IT WAS FOUND TO HAVE A PERICARDIAL EFFUSION UPON THE ROUTINE POST PROCEDURAL IMAGING. HENCE, A PERICARDIOCENTESIS WAS PERFORMED TO ADDRESS IT. THE PATIENT LEFT THE LAB IN A STABLE STATE, WAS ADMITTED FOR MONITORING OF THE EFFUSION, AND IT WAS LATER DISCHARGED IN STABLE CONDITION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PROCEDURE TOOK ABOUT 3 HOURS IN TOTAL WHERE THE TRANSSEPTAL ACCESS WAS OBTAINED IN AROUND TWO HOURS. NO ISSUES WITH THE VERSACROSS RF WIRE WERE NOTED DURING THE FIRST THREE ATTEMPTS. THE FIRST THREE ATT

  Patient problems: Pericardial Effusion

  MAUDE report 19609449 ↗
• MalfunctionJun 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION KIT WAS SELECTED FOR USE. UPON OPENING THE PACKAGE, A LEAK WAS NOTED IN ONE OF THE DEVICES. HENCE, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505237 ↗
• InjuryJul 12, 2023Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) IN LEFT ATRIAL APPENDAGE (LAA), A VERSACROSS CONNECT SOLUTION WAS SELECTED FOR USE AND PERFORATION HAPPENED ON THE RIGHT SIDE OF THE HEART WHILE ATTEMPTING TO GO TRANSSEPTAL. THERE WAS A BASELINE TRACE EFFUSION WHEN WE STARTED. JUST A NORMAL AMOUNT OF FLUID IN THE PERICARDIAL SPACE. THE PATIENT HAD A LIPOMATOUS SEPTUM (SUPERIORLY) AND A LARGE EUSTACHIAN VALVE THAT KEPT PUSHING THE TRANSSEPTAL SYSTEM OFF (WATCHMAN FXD DOUBLE CURVE AND VERSACROSS CONNECT). HENCE IN ORDER TO ATTEMPT TO GET AND MAINTAIN CONTACT WITH THE FOSSA OVALIS, A VERSACROSS STEERABLE WAS OPENED TO TRY TO GET TRANSSEPTAL. IT MADE CONTACT WITH THE SEPTUM INFERIORLY AND POSTERIORLY ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND RADIO FREQUENCY WAS NOT APPLIED AND HENCE NEVER CROSSED THE SEPTUM. APPROXIMATELY 10 MINUTES AFTER INSERTING THE STEERABLE VERSACROSS, THE PATIENT'S PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS NOTED ON THE ECHO. A DRAIN WAS PLACED AND PATIENT WAS TAKEN TO THE OPERATION ROOM (OR) WHERE A STERNOTOMY WITH A REPAIR AND A LEFT ATRIAL APPENDAGE LIGATION WAS PERFORMED. THE SURGEON NOTED A 4MM HOLE IN A THE TRANSVE

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 17305765 ↗
• InjuryJul 12, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) IN LEFT ATRIAL APPENDAGE (LAA), A VERSACROSS CONNECT SOLUTION WAS SELECTED FOR USE AND PERFORATION HAPPENED ON THE RIGHT SIDE OF THE HEART WHILE ATTEMPTING TO GO TRANSSEPTAL. THERE WAS A BASELINE TRACE EFFUSION WHEN WE STARTED. JUST A NORMAL AMOUNT OF FLUID IN THE PERICARDIAL SPACE. THE PATIENT HAD A LIPOMATOUS SEPTUM (SUPERIORLY) AND A LARGE EUSTACHIAN VALVE THAT KEPT PUSHING THE TRANSSEPTAL SYSTEM OFF (WATCHMAN FXD DOUBLE CURVE AND VERSACROSS CONNECT). HENCE IN ORDER TO ATTEMPT TO GET AND MAINTAIN CONTACT WITH THE FOSSA OVALIS, A VERSACROSS STEERABLE WAS OPENED TO TRY TO GET TRANSSEPTAL. IT MADE CONTACT WITH THE SEPTUM INFERIORLY AND POSTERIORLY ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND RADIO FREQUENCY WAS NOT APPLIED AND HENCE NEVER CROSSED THE SEPTUM. APPROXIMATELY 10 MINUTES AFTER INSERTING THE STEERABLE VERSACROSS, THE PATIENT'S PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS NOTED ON THE ECHO. A DRAIN WAS PLACED AND PATIENT WAS TAKEN TO THE OPERATION ROOM (OR) WHERE A STERNOTOMY WITH A REPAIR AND A LEFT ATRIAL APPENDAGE LIGATION WAS PERFORMED. THE SURGEON NOTED A 4MM HOLE IN A THE TRANSVE

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 17305749 ↗