VersaCross Access Solution VXSK0022 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00685447007432), received between Nov 15, 2024 and Mar 26, 2025 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE CTI LINE WAS PERFORMED IN THE RIGHT ATRIUM USING A NON-BOSTON SCIENTIFIC MAPPING CATHETER. AFTER THE CTI LINE WAS PERFORMED, THE PHYSICIAN PERFORMED TRANSEPTAL PUNCTURE WITH NO ISSUES REPORTED. ONCE ACROSS THE SEPTUM, THE VERSACROSS SHEATH WAS EXCHANGED FOR THE FARADRIVE SHEATH AND THE MAPPING CATHETER WAS INSERTED. IT WAS AT THIS POINT THAT THE PATIENT'S HEART RATE BECAME TACHYCARDIC AND HYPOTENSIVE WITH ONLY AN AVAILABLE READING OF MAP OF 24. THE BLOOD PRESSURE WAS THEN REATTEMPTED WITH A SYSTOLIC IN THE 60'S. THE PATIENT'S HEART RATE THEN DECLINED TO THE 50'S-40'S WHERE THEY WERE THEN PULSELESS ELECTRICAL ACTIVITY (PEA) AND REQUIRED RESUSCITATIVE EFFORTS. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SCAN DETECTED A PERICARDIAL EFFUSION WHICH LED TO CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND BLOOD WAS ADMINISTERED. THE PATIENT PASSED AWAY DESPITE THE EFFORTS OF THE LAB STAFF. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE PERICARDIAL EFFUSION WAS NOTED ON ICE IMAGE, BUT UNSURE OF EXACTLY

  Patient problems: Bradycardia; Cardiac Arrest; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 21699984 ↗
• MalfunctionFeb 3, 2025Difficult to Remove; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR WATCHMAN PROCEDURE. IT WAS MENTIONED THAT WHEN THE MECHANICAL GUIDEWIRE WAS INSERTED WITH VERSACROSS DILATOR OVER THE WIRE, THE MECHANICAL GUIDEWIRE GOT STUCK INTO THE DILATOR AND IT CANNOT BE REMOVED. THUS, THE DILATOR AND MECHANICAL GUIDEWIRE WERE REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING VERSACROSS RF WIRE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED. THE GUIDEWIRE GOT KINKED AND WAS STUCK INTO THE DILATOR, WHICH MADE IT DIFFICULT TO REMOVE THE GUIDEWIRE FROM THE DILATOR. WHEN THE GUIDEWIRE GOT STUCK, THE DISTAL TIP OF THE WIRE WAS EXPOSED PAST TO THE DISTAL END OF THE DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299440 ↗
• MalfunctionFeb 3, 2025Difficult to Remove; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking

  IT WAS MENTIONED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR WATCHMAN PROCEDURE. IT WAS MENTIONED THAT WHEN MECHANICAL GUIDEWIRE WAS INSERTED WITH DILATOR OVER THE WIRE, THE GUIDEWIRE GOT STUCK INTO THE DILATOR AND THE DILATOR CANNOT BE REMOVED. THUS, THE DILATOR AND MECHANICAL GUIDEWIRE WERE REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING VERSACROSS RF WIRE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS. THE GUIDEWIRE GOT KINKED AND WAS STUCK INTO THE DILATOR, WHICH MADE IT DIFFICULT TO REMOVE THE GUIDEWIRE FROM THE DILATOR. WHEN THE WIRE GOT STUCK, THE DISTAL TIP OF THE WIRE WAS EXPOSED PAST TO THE DISTAL END OF THE DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299412 ↗
• MalfunctionFeb 3, 2025Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THE MECHANICAL GUIDEWIRE BECAME STUCK IN THE VERSACROSS DILATOR. THE DEVICES WERE THEN REMOVED TOGETHER FROM THE PATIENT AND REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS. THE MECHANICAL GUIDEWIRE WAS EXPOSED TO THE PATIENT WHEN THE ISSUE OCCURRED. NO DAMAGE NOTED ON THE GUIDEWIRE PRIOR TO USE, ALTHOUGH THE GUIDEWIRE WAS NOTED TO BE KINKED WHEN IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297727 ↗
• MalfunctionJan 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A PVI AND PWI PROCEDURE. THE PROCEDURE HAS STARTED, WITH GROIN ACCESS ACHIEVED. AS THE VERSACROSS RF WIRE WAS BEING ADVANCED UP THE SHEATH, IT GOT STUCK AND WOULD NOT GO THROUGH THE ENTIRE LENGTH OF THE SHEATH. THIS WAS ATTEMPTED ABOUT 3 TIMES BEFORE A REPLACEMENT WAS SOUGHT. THE PRODUCT WAS REPLACED, AND TRANSEPTAL ACCESS WAS ACHIEVED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PRODUCT IS NOT AVAILABLE TO RETURN (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106957 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED AND THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION PROCEDURE FOR AN ATRIAL FIBRILLATION CASE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TRANSSEPTAL PUNCTURE TO THE LEFT ATRIUM, HOWEVER FELT UNCOMFORTABLE WITH THE POSITIONING BUT PROCEEDED. AFTER THE TRANSSEPTAL WAS PERFORMED, THERE WAS A SUDDEN DROP IN PATIENT BLOOD PRESSURED NOTED. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGES REVIEW BEGAN AND A PE WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PHYSICIAN WAS AWARE THAT THE PUNCTURE SITE WAS PROBABLY GOING TO BE TOO SUPERIOR TO WHAT IS RECOMMENDED AND PROCEEDED. THERE IS NO REASON TO BELIEVE THAT THE DEVICE MALFUNCTIONED AND CAUSED THE EFFUSION. THE ACTIVATED CLOTTING TIME (ACT) WAS NOT AT THERAPEUTIC LEVELS BECAUSE THE PHYSICIAN DOES NOT ADMINISTER THE HEPARIN UNTIL AFTER THE TRANSSEPTAL PUNCTURE HAS OCCURRED AND UNTIL THE WIRE IN THE LEFT ATRIUM. THERE WAS NO DIFFICULTY MANEUVERING THE SHEATH. THE LOCATION OF THE PERFORATION COULD NOT BE LOCATED WITH ICE OR W

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

  MAUDE report 20693909 ↗