VersaCross Access Solution VXSK0031 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00685447011828), received between Jan 6, 2023 and Oct 30, 2024 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION OCCURRED AND THE PROCEDURE WAS CANCELLED. IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, PRIOR TO TRANSSEPTAL, THAT WAS ATTEMPTED SEVERAL TIMES, A PERICARDIAL EFFUSION DEVELOPED IN THE PERICARDIUM. A PERICARDIAL TAP WAS PERFORMED TO MANAGE THE EFFUSION AND THE PROCEDURE WAS ABORTED. PATIENT HAS BEEN ADMITTED TO HOSPITAL AND EXPECTED TO FULLY RECOVER. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. IN THE PHYSICIAN'S OPINION, THE DEVICE OR PROCEDURE DID NOT CONTRIBUTED TO THE ADVERSE EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 20569532 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CARDIAC PERFORATION AND PERICARDIAL EFFUSION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A VERSACROSS ACCESS KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS UTILIZED RADIAL INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND FLUOROSCOPY TO NAVIGATE TRANSSEPTAL PUNCTURE. UPON CROSSING, THE PHYSICIAN RECEIVED AN UNUSUAL PRESSURE WAVEFORM READOUTS NOT INDICATIVE OF BEING IN THE LEFT ATRIUM. THE PHYSICIAN PROCEEDED TO ADVANCE A NON-BOSTON SCIENTIFIC MAPPING CATHETER THROUGH THE VERSACROSS SHEATH TO CHECK FOR SIGNALS INDICATING THE LOCATION HOWEVER THE CATHETER HAD NO SIGNALS ONCE ADVANCED OUT OF THE SHEATH. THE PHYSICIAN NOTED THE CATHETER APPEARED TO BE OUTSIDE OF THE CARDIAC SILHOUETTE ON FLUOROSCOPY. THE PHYSICIAN PULLED THE SHEATH BACK INTO THE RIGHT ATRIUM AND PERFORMED A CTI FLUTTER ABLATION WITH A NON-BOSTON SCIENTIFIC RADIO FREQUENCY CATHETER IN THE RIGHT ATRIUM. EFFUSION WAS CHECKED POST- PROCEDURE AND WAS CONFIRMED ON ICE. IT WAS NOTED THAT THE PERFORATION OCCURRED IN THE DOME OF THE LEFT ATRIUM. THE PHYSICIAN THEN PERFORMED A PERICARDIOCENTESIS ON THE PATIENT, AND ONCE COMPLETE THE PATIENT WAS TAKEN TO HOLDING BUT THE DI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20409705 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CARDIAC PERFORATION AND PERICARDIAL EFFUSION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A VERSACROSS ACCESS KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS UTILIZED RADIAL INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND FLUOROSCOPY TO NAVIGATE TRANSSEPTAL PUNCTURE. UPON CROSSING, THE PHYSICIAN RECEIVED AN UNUSUAL PRESSURE WAVEFORM READOUTS NOT INDICATIVE OF BEING IN THE LEFT ATRIUM. THE PHYSICIAN PROCEEDED TO ADVANCE A NON-BOSTON SCIENTIFIC MAPPING CATHETER THROUGH THE VERSACROSS SHEATH TO CHECK FOR SIGNALS INDICATING THE LOCATION HOWEVER THE CATHETER HAD NO SIGNALS ONCE ADVANCED OUT OF THE SHEATH. THE PHYSICIAN NOTED THE CATHETER APPEARED TO BE OUTSIDE OF THE CARDIAC SILHOUETTE ON FLUOROSCOPY. THE PHYSICIAN PULLED THE SHEATH BACK INTO THE RIGHT ATRIUM AND PERFORMED A CTI FLUTTER ABLATION WITH A NON-BOSTON SCIENTIFIC RADIO FREQUENCY CATHETER IN THE RIGHT ATRIUM. EFFUSION WAS CHECKED POST- PROCEDURE AND WAS CONFIRMED ON ICE. IT WAS NOTED THAT THE PERFORATION OCCURRED IN THE DOME OF THE LEFT ATRIUM. THE PHYSICIAN THEN PERFORMED A PERICARDIOCENTESIS ON THE PATIENT, AND ONCE COMPLETE THE PATIENT WAS TAKEN TO HOLDING BUT THE DI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20409651 ↗
• MalfunctionSep 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARADRIVE SHEATH THEY WERE UNABLE TO ADVANCE THE SHEATH OVER THE VERSACROSS RF WIRE. WHILE INTRODUCING THE SHEATH INTO THE PATIENT THEY FOUND THE DEVICE KEPT GETTING STUCK ON THE END OF THE INSULATION STEP UP" FOR THE VERSACROSS WIRE. EVENTUALLY THE FARADRIVE DILATOR BECAME CHEWED UP AND THE TIP LOOKED SHARP. THE SHEATH WAS REPLACED WITH ANOTHER FARADRIVE SHEATH AND DILATOR, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20285548 ↗
• MalfunctionJul 2, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Defective Device; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Defective Device

  IT WAS REPORTED THAT AN VERSACROSS ACCESS SOLUTION WAS SELECTED USE DURING A CARDIAC ABLATION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE OUTER BOX WAS DAMAGED (TEAR/HOLED). ONCE THE OUTER BOX WAS OPENED IN ATTEMPTED TO USE THE INTERNAL PRODUCT, THE INTERNAL PACKAGE WAS ALSO OBSERVED TO BE DAMAGED. THE LAB STAFF NOTED THAT THE DAMAGED FROM OUTER BOX CAUSED THE DAMAGE TO THE INNER POUCH AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THUS, THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655330 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE ACCESS WAS GRANTED AND THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED WITHOUT ANY ISSUES. AFTER TSP, WHEN THE VERSACROSS SHEATH WAS BEING PLACED INTO THE LEFT UPPER PULMONARY VEIN, THERE WAS DIFFICULTY TO LOCATE THE VERSACROSS RF WIRE, SINCE IT WAS VERY POSTERIOR. THE VERSACROSS SHEATH WAS EXCHANGED FOR THE WATCHMAN SHEATH, AND IT WAS STILL NOT POSSIBLE TO VISUALIZE THE RF WIRE. THE WATCHMAN SHEATH APPEARED BE MORE POSTERIOR IN THE LEFT ATRIUM. THUS, A NON-BOSTON SCIENTIFIC PIGTAIL WAS PLACED IN THE APPENDAGE AND A CONTRAST INJECTION WAS COMPLETED. THEREFORE, A SMALL CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS NOTED. THE PATIENT REMAINED STABLE, SO THE PHYSICIAN COMPLETED THE IMPLANT OF THE CLOSURE DEVICE. A PERICARDIOCENTESIS WAS COMPLETED TO TREAT THE EFFUSION REMOVING 450ML OF BRIGHT RED FLUID. THE PATIENT WAS REPORTED TO BE DOING WELL BUT REMAINED IN THE HOSPITAL. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFA

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19569884 ↗
• InjuryJun 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE ACCESS WAS GRANTED AND THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED WITHOUT ANY ISSUES. AFTER TSP, WHEN THE VERSACROSS SHEATH WAS BEING PLACED INTO THE LEFT UPPER PULMONARY VEIN, THERE WAS DIFFICULTY TO LOCATE THE VERSACROSS RF WIRE, SINCE IT WAS VERY POSTERIOR. THE VERSACROSS SHEATH WAS EXCHANGED FOR THE WATCHMAN SHEATH, AND IT WAS STILL NOT POSSIBLE TO VISUALIZE THE RF WIRE. THE WATCHMAN SHEATH APPEARED BE MORE POSTERIOR IN THE LEFT ATRIUM. THUS, A NON-BOSTON SCIENTIFIC PIGTAIL WAS PLACED IN THE APPENDAGE AND A CONTRAST INJECTION WAS COMPLETED. THEREFORE, A SMALL CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS NOTED. THE PATIENT REMAINED STABLE, SO THE PHYSICIAN COMPLETED THE IMPLANT OF THE CLOSURE DEVICE. A PERICARDIOCENTESIS WAS COMPLETED TO TREAT THE EFFUSION REMOVING 450ML OF BRIGHT RED FLUID. THE PATIENT WAS REPORTED TO BE DOING WELL BUT REMAINED IN THE HOSPITAL. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFA

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19567602 ↗
• MalfunctionFeb 26, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE ATTEMPTING TO GO TRANSSEPTAL, THE RADIO FREQUENCY (RF) DID NOT WORK. HENCE, IN ORDER TO RESOLVE THE ISSUE, A NEW VERSACROSS KIT WAS OPENED TO BE USED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785561 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MITRA CLIP PROCEDURE TO TREAT MITRAL REGURGITATION, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. WHILE ATTEMPTING FOR THE TRANSSEPTAL PUNCTURE (TSP), AN UNKNOWN ERROR MESSAGE WAS DISPLAYED. HENCE TO RESOLVE THE ISSUE, A NEW KIT WAS USED. PRIOR TO OPENING THE SECOND KIT, THE DILATOR MAY HAVE CROSSED ON ITS OWN WITH NO WIRE IN PLACE. A SECOND KIT WAS OPENED NOT KNOWING THAT THE DILATOR HAD CROSSED. A PERICARDIAL EFFUSION WAS NOTED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A PERICARDIOCENTESIS WAS PERFORMED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Pericardial Effusion

  MAUDE report 18282934 ↗
• MalfunctionDec 5, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY WERE UNABLE TO USE THE KIT DUE TO GENERATOR DISPLAYING ERROR CODE (A014). THE CONNECTOR CABLE WAS REPLACED AND ISSUE PERSISTED. PROCEDURE WAS THEN CANCELLED AND RESCHEDULED. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED OF AT THE FACILITY. THE BMC RF GENERATOR WERE IN THE READY MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266367 ↗
• MalfunctionDec 5, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY WERE UNABLE TO USE THE KIT DUE TO GENERATOR DISPLAYING ERROR CODE (A014). THE CONNECTOR CABLE WAS REPLACED AND ISSUE PERSISTED. PROCEDURE WAS THEN CANCELLED AND RESCHEDULED. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED OF AT THE FACILITY. THE BMC RF GENERATOR WERE IN THE READY MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266137 ↗
• MalfunctionAug 3, 2023Defective Device; Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Defective Device; Device-Device Incompatibility; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE VERSACROSS RF WIRE WAS INSERTED INTO A NON-BOSTON INTRODUCER SHEATH, AND ADVANCED INTO THE HEART (A NON-BOSTON SCIENTIFIC TIP STRAIGHTENER WAS USED TO INSERT VERSACROSS RF WIRE THROUGH INTRODUCER SHEATH AND INTO THE BODY). THUS, AFTER REMOVING THE NON-BOSTON INTRODUCER SHEATH, THE VERSACROSS SHEATH/DILATOR WERE BACKLOADED IN THE BACK OF THE VERSACROSS RF WIRE (BACK OF THE WIRE INTO THE TIP OF THE DILATOR). AT A CERTAIN POINT, THE COATING OF THE WIRE CAME OFF AND BUNCHED UP AT A POINT WHERE THE SHEATH AND DILATOR COULD NO LONGER BE ADVANCED OVER THAT SECTION OF THE WIRE. THE INSULATION WAS INTACT BUT PEELED BACK AT PROXIMAL END. HENCE TO RESOLVE THE ISSUE, A NEW KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453578 ↗
• MalfunctionJul 18, 2023Material Perforation; Material Split, Cut or Torn; Material Perforation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION (ATRIAL FIBRILLATION) PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN NOTICED THAT THE INNER LUMEN OF THE SHEATH WAS TORN/DAMAGED WHEN USED WITH A NON-BOSTON SCIENTIFIC MAPPING CATHETER. THERE WERE FRAGMENTS OF SHEATH IDENTIFIED WRAPPED AROUND MAPPING CATHETER. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346474 ↗
• MalfunctionJun 28, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT NON-VALVULAR ATRIAL FIBRILLATION (NVAF), A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE VERSACROSS RADIO FREQUENCY WIRE (0.035 230 CM) WAS INSERTED INTO THE VERSACROSS SHEATH ATTEMPTED TO GO TRANSSEPTAL PUNCTURE IN INFERIOR VENA CAVA (IVC). THE PHYSICIAN FELT RESISTANCE SO HE STOPPED PULLED OUT THE WIRE AND IT WAS NOTICED THAT THE WIRE WAS FRAYED. THE PHYSICIAN CONFIRMED THE PIGTAIL SHAPE WAS FINE (NO KINK/CURVE OBSERVED PRIOR TO INSERTING) AND THEY DID NOT EXPERIENCE ANYTHING DIFFERENT WITH THE WIRE PERFORMANCE. NO DIFFICULT ANATOMY NOTED DURING THE CASE. THE ENTIRE KIT (SHEATH AND WIRE) WAS REMOVED FROM THE BODY. A NEW VERSACROSS ACCESS SOLUTION WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221149 ↗
• MalfunctionJun 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE DURING A LEFT ATRIUM APPENDAGE CLOSURE (WATCHMAN) TO TREAT A STROKE PREVENTION FOR FIBRILLATION. DURING THE PREPARATION FOR THE PROCEDURE, UPON OPENING THE PACKAGE, IT WAS NOTICED A FRACTURE ON THE MECHANICAL GUIDEWIRE COMPONENT OF THE VERSACROSS KIT, AS THE PHYSICIAN WAS PREPPING TO INSERT VIA THE VERSACROSS SHEATH. THE DEVICE WAS NOT BROKEN COMPLETELY IN TWO PIECES. IT IS UNSURE IF THE STRETCH, THAT WAS NOT MENTIONED BY THE PHYSICIAN. NO DAMAGE TO THE PACKAGE WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088742 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CARDIOLOGY PROCEDURE, AFTER THE TRANSSEPTAL PUNCTURE WAS COMPLETED WITH THE VERSACROSS RF WIRE (VXW) FROM THE VERSACROSS ACCESS SOLUTION KIT, A PIECE OF TISSUE DEBRIS WAS NOTED TO BE ADHERED TO THE VXW ON INTRACARDIAC ECHOCARDIOGRAPHY. THE DEBRIS WAS ASPIRATED, AND THE PROCEDURE CONTINUED. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 16117815 ↗