VersaCross Access Solution VXSK0021 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00685447011729), received between Apr 12, 2023 and Oct 25, 2024 — classified as 1 death, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 10, 2025Open, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2103-2025 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING WATCHMAN AND FARAPULSE PULMONARY VEIN ISOLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THE VERSACROSS RF WIRE WAS DEFECTIVE WITH BUNCHING INSULATION. THE DEVICE WAS REPLACED, AND 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 20532380 ↗
• MalfunctionOct 9, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 26-SEP-2024. IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. PRIOR TO THE PROCEDURE, THE USER MENTIONED THAT THE VERSACROSS RF WIRE WAS KINKED AFTER REMOVING THE DEVICE FROM THE PACKAGING AND COULD NOT BE USED. A NEW KIT WAS THEN OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT WILL BE RETURNING FOR ANALYSIS. HOWEVER, ANALYSIS REVEALED THAT THE VERSACROSS RF WIRE HAS ALSO AN INSULATION DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409860 ↗
• InjuryJun 11, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. THE PATIENT HAS ARRIVED, IT WAS INTUBATED, AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING WAS OBTAINED. THE FIRST TRANSSEPTAL PUNCTURE WAS PERFORMED WITH NO ISSUES, HOWEVER SINCE THE VERSACROSS RF WIRE WAS NOT VISUALIZED ONCE IN THE LEFT ATRIUM (LA), IT WAS DECIDED TO GO FOR A SECOND TRANSSEPTAL PUNCTURE, WHEN AN EFFUSION WAS CHECKED AND NOTICED A TRACE PERICARDIAL EFFUSION (INFERIOR AND POSTERIOR) AND A PERFORATION CONFIRMED. THUS, THE SECOND TRANSSEPTAL ATTEMPT WAS NOT PERFORMED. THEN, PROTAMINE WAS GIVEN TO THE PATIENT AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS MONITORED FOR 30 MINUTES AND NO CHANGE IN THE EFFUSION WAS NOTED. THEREFORE, THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL FOR FURTHER MONITORING, AND IT WAS EXPECTED TO FULLY RECOVER. NO INTERVENTION WAS REPORTED TO BE REQUIRED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). PRIOR TO THE PROCEDURE, NO PE WAS NOTED. THE PATIENT WAS NOT ON WARFARIN AT THIS

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19510464 ↗
• InjuryJun 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. THE PATIENT HAS ARRIVED, IT WAS INTUBATED, AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING WAS OBTAINED. THE FIRST TRANSSEPTAL PUNCTURE WAS PERFORMED WITH NO ISSUES, HOWEVER SINCE THE VERSACROSS RF WIRE WAS NOT VISUALIZED ONCE IN THE LEFT ATRIUM (LA), IT WAS DECIDED TO GO FOR A SECOND TRANSSEPTAL PUNCTURE, WHEN AN EFFUSION WAS CHECKED AND NOTICED A TRACE PERICARDIAL EFFUSION (INFERIOR AND POSTERIOR) AND A PERFORATION CONFIRMED. THUS, THE SECOND TRANSSEPTAL ATTEMPT WAS NOT PERFORMED. THEN, PROTAMINE WAS GIVEN TO THE PATIENT AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS MONITORED FOR 30 MINUTES AND NO CHANGE IN THE EFFUSION WAS NOTED. THEREFORE, THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL FOR FURTHER MONITORING, AND IT WAS EXPECTED TO FULLY RECOVER. NO INTERVENTION WAS REPORTED TO BE REQUIRED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). PRIOR TO THE PROCEDURE, NO PE WAS NOTED. THE PATIENT WAS NOT ON WARFARIN AT THIS

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19510463 ↗
• MalfunctionJun 4, 2024Material Perforation; Defective Device; Material Deformation; Material Perforation; Defective Device; Material Deformation

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. AFTER OPENING THE PACKAGE, PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, THE PHYSICIAN NOTED THAT THE DISTAL END OF THE DILATOR TIP WAS DAMAGED AND BENT NEARLY TO THE POINT WHICH POTENTIALLY COULD HAVE FALLEN OFF. THE TIP ALMOST SEEMED DETACHABLE OR FRAGMENTED FROM THE TIP. THE METHOD OF DEVICE REMOVAL FROM THE PACKAGING COULD HAVE POTENTIALLY CAUSED THE DAMAGE. HENCE, THE DEVICE WAS REPLACED, AND 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 19459944 ↗
• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED TO CLEAR THROMBUS FROM PULMONARY ARTERY. IMMEDIATELY UPON GOING TRANSSEPTAL PUNCTURE, THE BLOOD PRESSURE TANKED, HEART RATE ROSE AND A LARGE EFFUSION WAS NOTED. A PERICARDIAL ACCESS WAS ACHIEVED, AND TAPPING WAS CONTINUOUS, BUT EFFUSION WAS NOT RESOLVING. THE PHYSICIAN DECIDED TO PLACE THE WATCHMAN DEVICE TO TRY TO SLOW THE BLEEDING AS THE ANGIOGRAM SHOWED SOME DYE EXTRAPOLATION WAS SEEN OUT OF THE APPENDAGE. THE EFFUSION STARTED TO GET SLIGHTLY BETTER WITH CONTINUOUS TAPPING. THE PATIENT CODED AND COMPRESSIONS WERE STARTED ALONG WITH INTUBATION. THE SURGERY WAS CALLED AND CRACKED THE CHEST BUT THEY COULD NOT GET THE PATIENT HEART TO RESTART AND THE PATIENT PASSES AWAY ON THE TABLE. IN THE PHYSICIAN OPINION THE VERSACROSS WIRE LACERATED THE LEFT ATRIAL APPENDAGE (LAA). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED THERE WAS NO THROMBUS PRESENT IN PA (PULMONARY ARTERY). NO ISSUES WERE NOTED DURING TSP, W

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

  MAUDE report 18949057 ↗
• MalfunctionFeb 28, 2024Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A CRYOABLATION PROCEDURE INDICATED FOR A CASE OF ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THE MECHANICAL GUIDEWIRE (MGW) WIRE GOT STUCK IN THE VERSACROSS SHEATH AND COULD NOT BE REMOVED. THE ISSUE OCCURRED WHEN THE PHYSICIAN WAS INSERTING THE VERSACROSS SHEATH TOWARDS THE RIGHT ATRIUM, PRIOR TO TRANSSEPTAL. THE GUIDEWIRE AND SHEATH WERE REMOVED ALTOGETHER, AND THE DEVICE WAS REPLACED (DIFFERENT DEVICE, SAME MODEL). THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS. NO KINKS WERE NOTED ON THE GUIDEWIRE AFTER REMOVAL FROM THE BODY OR PRIOR TO USE. THE PATIENT DID NOT HAVE ANY IMPLANTED DEVICES DURING THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802388 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A BRADYCARDIA AND CARDIAC ARREST OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A POLARX CRYO ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) PULMONARY VEIN ISOLATION ABLATION, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PHYSICIAN GAINED ACCESS TO PERFORM THE TRANSSEPTAL PUNCTURE TWICE. AFTER THE TRANSSEPTAL PUNCTURE, THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC. PATIENT THEN WENT INTO FULL CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR ABOUT TWENTY MINUTES AND AN ADDITIONAL DEVICE WAS IMPLANTED TO ASSIST LEFT VENTRICULAR (LV). THE PATIENT RETURNED TO BASELINE. THE PROCEDURE WAS CANCELLED AND PATIENT WAS TAKEN TO THE INTENSIVE CARE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED THAT THE INCIDENT HAPPENED JUST A FEW MINUTES AFTER THE SECOND TRANSSEPTAL. THERE WAS NO AIR EMBOLISM ON ANY OF THE TECHNOLOGY WITNESSED. THERE WAS NO DEFINITIVE ST ELEVATION APPRECIATED AT TIME OF INCIDENT BUT AFTERWARDS ELEVATION NOTED ON INFERIOR LEADS. ICE WAS IN PLACE AND THERE WAS NOT AN EFFUSION. THE PHYSICIAN ALWAYS PERFORMS TWO TRANSSEPTAL PUNCTURES FOR ATRIAL F

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 18553885 ↗
• MalfunctionJan 10, 2024Defective Device; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking; Defective Device; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A CRYO PROCEDURE. THE MECHANICAL GUIDEWIRE GOT STUCK INSIDE THE DILATOR AND COULD NOT ADVANCE THE WIRE. THUS, A NEW VERSACROSS KIT WAS OPENED TO BE USED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE MECHANICAL GUIDEWIRE WAS DAMAGED/DEFECTIVE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490317 ↗
• MalfunctionNov 13, 2023Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION. THE VERSACROSS RF WIRE GOT STUCK IN THE VERSACROSS DILATOR, WHILE MAKING THE TRANSEPTAL EXCHANGE. THUS, THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18122916 ↗
• MalfunctionJul 12, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR TRANSEPTAL ACCESS FOR A CRYOABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION. IT WAS REPORTED THAT DURING THE PROCEDURE THE MECHANICAL GUIDEWIRE WAS UNTANGLED; IT WAS MANGLED IN INTRODUCING INTO VERSACROSS DILATOR/SHEATH. THE VERSACROSS 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 17306684 ↗
• MalfunctionJun 28, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB) PROCEDURE. DURING PREPARATION, ONCE THE MECHANICAL GUIDE WIRE WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED FRACTURED/KINKED. THUS, A NEW KIT HAD TO BE OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218687 ↗
• MalfunctionJun 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE, IT WAS NOTED THAT THE VERSACROSS KIT WAS RECEIVED WITH NO LABEL ON THE INNER PACKAGE (POUCH). THUS, THE KIT WAS NOT USED, AND IT WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082911 ↗
• MalfunctionJun 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE, IT WAS NOTED THAT THE VERSACROSS KIT WAS RECEIVED WITH NO LABEL ON THE INNER PACKAGE (POUCH). THUS, THE KIT WAS NOT USED, AND IT WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082907 ↗
• MalfunctionApr 12, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE, A VERSACROSS SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS DIFFICULT TO CROSS THE SEPTUM. NO FURTHER DETAILS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE LOT NUMBER PROVIDED COULD NOT BE POPULATED IN THE SYSTEM. IT WAS FURTHER REPORTED THAT THE PHYSICIAN BELIEVES IT WAS TORTUOUS ANATOMY WITH CALCIUM BUILD UP ON THE SEPTUM. HE BELIEVES THE TRANSITION FROM THE DILATOR TO THE SHEATH GAVE THEM ISSUE. THEY ENDED UP TRYING A NEW SHEATH AND CROSSED JUST FINE. HE SAID THIS IS A PRETTY COMMON EVENT WHEN THERE IS A LOT OF CALCIUM BUILD UP ON THE SEPTUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726407 ↗