VersaCross Large Access Solution VLAK0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00685447012535), received between Apr 13, 2023 and Sep 12, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A VERSACROSS LARGE ACCESS SOLUTION KIT WAS SELECTED FOR ATRIAL FIBRILLATION (A FIB) ABLATION. PRIOR TO THE PROCEDURE, DURING PREPARATION, IT WAS MENTIONED THAT WHEN THE STERILE PACKAGING FOR THE KIT WAS OPENED, A LOOSE LONG BLACK HAIR WAS OBSERVED TO BE INSIDE THE STERILE PACKAGING. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207941 ↗
• MalfunctionApr 15, 2024Device-Device Incompatibility; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INSERTION OF THE MITRA CLIP PROCEDURE TO TREAT MITRAL VALVE, A VERSACROSS LARGE ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT VERSACROSS DILATOR WAS NOT ABLE TO BE FRONT LOAD WITH THE VERSACROSS RF WIRE. THE TROUBLESHOOTING STEPS INCLUDED BACK LOADING THE DILATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER VERSACROSS KIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT WAS EXPECTED TO BE RETURNED. HOWEVER, ANALYSIS OF THE DEVICE RETURNED REVEALED A SCUFFING OF THE DILATOR CURVE, AND A MINOR TIP DEFECT OUTSIDE OF LUMEN, EXTRA MATERIAL NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106884 ↗
• MalfunctionAug 17, 2023Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS LARGE ACCESS KIT WAS SELECTED FOR USE. THE MECHANICAL GUIDEWIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) AND THE DILATOR WAS POSITIONED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE, IT GOT STUCK IN THE DILATOR. HENCE THE ALL DEVICES WERE REMOVED TOGETHER. THE PHYSICIAN TRIED FORCING TO PULL THE WIRE USING FORCEPS AND IT CAME FREE FROM THE DILATOR. TO RESOLVE THE ISSUE, A NEW VERSACROSS LARGE ACCESS KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CLARIFIED THERE WERE NO DAMAGE NOTED TO THE WIRE WHEN IT WAS REMOVED FROM PACKAGING OR BODY. THE GUIDEWIRE WAS TRACKED FROM THE RIGHT GROIN VENOUS ACCESS SITE TO THE SVC BUT NO DIFFICULTY NOTED WITH PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565312 ↗
• MalfunctionAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION, THE TRANSEPTAL PUNCTURE WAS THEN PERFORMED AND UPON CROSSING THE INTERATRIAL SEPTUM (IAS), A VERSACROSS RF WIRE WAS SENT INTO THE LEFT INFERIOR PULMONARY VEIN (LIPV), BUT THE VERSACROSS RF WIRE HIT THE TIP OF THE LIMBUS. THE VERSACROSS SYSTEM WAS EXCHANGED FOR THE WATCHMAN TRUSEAL DOUBLE CURVE SHEATH, BUT PRIOR TO THE WATCHMAN SHEATH CROSSING THE IAS, IT WAS NOTED THAT A SMALL HYPERMOBILE ECHODENSITY HAD FORMED ON THE TIP OF THE LIMBUS. IT MEASURED APPROXIMATELY 3.5 MM IN LENGTH. THE WATCHMAN SHEATH WAS STILL CROSSED INTO THE LEFT ATRIUM (LA), THE VERSACROSS RF WIRE WAS PULLED BACK AND REPLACED WITH A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER INTO THE LEFT ATRIAL APPENDAGE (LAA). THE AFOREMENTIONED HYPERMOBILE ECHODENSITY WAS CONTINUOUSLY OBSERVED AND AT THIS TIME WAS DEEMED A CLOT. ADDITIONAL HEPARIN WAS GIVEN AND AFTER ROUGHLY 5-10 MINUTES THE DECISION WAS MADE TO CANCEL THE PROCEDURE. IT WAS STATED THAT THIS WAS CAUSED BY THE WIRE HITTING THE TIP OF THE LIMBUS AND THAT THE PATIENT WAS LIKELY HYPERCOAGULABLE. ANOTHER PROCEDURE WILL BE SCHEDULED. THE PATIENT IS STABLE AND DOING WELL. THE DEVICE WILL NOT BE RETURNED

  Patient problems: Perforation; Thrombosis/Thrombus

  MAUDE report 17459418 ↗
• MalfunctionApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION, THE TRANSEPTAL PUNCTURE WAS THEN PERFORMED AND UPON CROSSING THE INTERATRIAL SEPTUM (IAS), A VERSACROSS RF WIRE WAS SENT INTO THE LEFT INFERIOR PULMONARY VEIN (LIPV), BUT THE VERSACROSS RF WIRE HIT THE TIP OF THE LIMBUS. THE VERSACROSS SYSTEM WAS EXCHANGED FOR THE WATCHMAN TRUSEAL DOUBLE CURVE SHEATH, BUT PRIOR TO THE WATCHMAN SHEATH CROSSING THE IAS, IT WAS NOTED THAT A SMALL HYPERMOBILE ECHODENSITY HAD FORMED ON THE TIP OF THE LIMBUS. IT MEASURED APPROXIMATELY 3.5 MM IN LENGTH. THE WATCHMAN SHEATH WAS STILL CROSSED INTO THE LEFT ATRIUM (LA), THE VERSACROSS RF WIRE WAS PULLED BACK AND REPLACED WITH A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER INTO THE LEFT ATRIAL APPENDAGE (LAA). THE AFOREMENTIONED HYPERMOBILE ECHODENSITY WAS CONTINUOUSLY OBSERVED AND AT THIS TIME WAS DEEMED A CLOT. ADDITIONAL HEPARIN WAS GIVEN AND AFTER ROUGHLY 5-10 MINUTES THE DECISION WAS MADE TO CANCEL THE PROCEDURE. IT WAS STATED THAT THIS WAS CAUSED BY THE WIRE HITTING THE TIP OF THE LIMBUS AND THAT THE PATIENT WAS LIKELY HYPERCOAGULABLE. ANOTHER PROCEDURE WILL BE SCHEDULED. THE PATIENT IS STABLE AND DOING WELL. THE DEVICE WILL NOT BE RETURNED

  Patient problems: Perforation; Thrombosis/Thrombus

  MAUDE report 16735264 ↗