VersaCross Large Access Solution VLAK0009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447012481), received between Oct 5, 2023 and Aug 13, 2024 — classified as 2 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, A VERSACROSS LARGE ACCESS KIT WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE SUCCESSFULLY. THEN, WHILE ATTEMPTING TO EXCHANGE THE LARGE ACCESS DILATOR (VLA) FOR A VIZIGO SHEATH, IT WAS NOTED THAT THERE WAS DIFFICULTY ADVANCING THE VLA DILATOR OVER THE VERSACROSS RF WIRE, AND THE COATING OF THE VERSACROSS WIRE STARTED TO BUCKLE AND THEN DISLODGED FROM THE WIRE (AT THE PROXIMAL END), IT WAS PEELED BACK BUT YET INTACT. HENCE, THE PHYSICIAN REPLACED THE VLA DILATOR OVER THE WIRE, BUT HAD DIFFICULTY DOING SO AND EXCHANGED THE WIRE OUT FOR ANOTHER ONE OF THE SAME TYPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971875 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. A VERSACROSS LARGE ACCESS SYSTEM KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS EXPERIENCING DIFFICULTY CROSSING THE INTRA ATRIAL SEPTUM AND EVEN AFTER MULTIPLE ATTEMPTS, THE IDEAL PUNCTURE SITE COULD NOT BE ACHIEVED. WHILE ATTEMPTING TO SECURE THE TRANSSEPTAL PUNCTURE SITE, A PERICARDIAL EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). HENCE THE PROCEDURE WAS CANCELLED. PERICARDIAL TAP WAS PERFORMED HOWEVER THE EFFUSION CONTINUED TO GROW VERY QUICK AND BLEED. THE PATIENT WAS THEN SENT TO THE OPERATING ROOM FOR THE CARDIOVASCULAR SURGERY. AS PER THE SURGEON, THE PATIENT HAD A SMALL TEAR AT THE JUNCTURE OF THE RIGHT ATRIUM/INFERIOR VENA CAVA (IVC). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER ADVISED, THERE WAS A PERFORATION, SITE IS UNKNOWN AT THE TIME OF PROCEDURE HOWEVER SUBSTANTIAL ENOUGH FLUID TO CAUSE A TEMPORARY DROP IN BLOOD PRESSURE. THERE WAS NO PE NOTED ON TEE PRIOR TO THE PROCEDURE. THERE WAS DIFFICULTY LOCATING THE CORRECT TSP SITE WHICH REQUIRED ADDITIONAL MANEUVERING IN THE RIGHT ATRIUM. NO DIFFICULT PATIENT ANATOMY NOTED. AT LEAST

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

  MAUDE report 17881901 ↗
• InjuryOct 5, 2023Difficult to Advance; Positioning Problem; Difficult to Advance; Positioning Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. A VERSACROSS LARGE ACCESS SYSTEM KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS EXPERIENCING DIFFICULTY CROSSING THE INTRA ATRIAL SEPTUM AND EVEN AFTER MULTIPLE ATTEMPTS, THE IDEAL PUNCTURE SITE COULD NOT BE ACHIEVED. WHILE ATTEMPTING TO SECURE THE TRANSSEPTAL PUNCTURE SITE, A PERICARDIAL EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). HENCE THE PROCEDURE WAS CANCELLED. PERICARDIAL TAP WAS PERFORMED HOWEVER THE EFFUSION CONTINUED TO GROW VERY QUICK AND BLEED. THE PATIENT WAS THEN SENT TO THE OPERATING ROOM FOR THE CARDIOVASCULAR SURGERY. AS PER THE SURGEON, THE PATIENT HAD A SMALL TEAR AT THE JUNCTURE OF THE RIGHT ATRIUM/INFERIOR VENA CAVA (IVC). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER ADVISED, THERE WAS A PERFORATION, SITE IS UNKNOWN AT THE TIME OF PROCEDURE HOWEVER SUBSTANTIAL ENOUGH FLUID TO CAUSE A TEMPORARY DROP IN BLOOD PRESSURE. THERE WAS NO PE NOTED ON TEE PRIOR TO THE PROCEDURE. THERE WAS DIFFICULTY LOCATING THE CORRECT TSP SITE WHICH REQUIRED ADDITIONAL MANEUVERING IN THE RIGHT ATRIUM. NO DIFFICULT PATIENT ANATOMY NOTED. AT LEAST

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

  MAUDE report 17879185 ↗