VersaCross Access Solution VXSK0021 (UDI 00685447017240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00685447017240), received between Dec 4, 2024 and Jul 30, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced Pericardial Effusion.During a Pulsed Field Ablation (PFA) procedure for the treatment of atrial fibrillation (AF), a VersaCross Access Solution was selected for use. Ultrasound guidance was used throughout the procedure. Prior to the event, the physician reported difficulty positioning a coronary sinus (CS) catheter due to challenging CS anatomy. Transseptal TSP) was successfully completed using a VersaCross RF Wire with a single application of RF energy. No resistance was reported during guidewire advancement, no multiple attempts were required to position the VersaCross Dilator on the septum, and no issues were reported with the RF wire during transseptal access. Immediately following completion of the TSP, intracardiac echocardiography (ICE) imaging revealed a pericardial effusion that appeared to be increasing in size. An echocardiography specialist subsequently assessed the finding and reported the effusion to be associated with the coronary sinus. At the time the effusion was identified, a non-Boston Scientific catheter was positioned across the septum. No ablation had been performed. The procedure was subsequently terminated. The pa

  Patient problems: Pericardial Effusion

  MAUDE report 50088147 ↗
• MalfunctionApr 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. AFTER THE SHEATH WAS ACROSS THE SEPTUM, THE PHYSICIAN NOTICED THAT BLOOD WAS DRIPPING OUT OF THE BACK OF THE HEMOSTATIC VALVE. THE PHYSICIAN OPTED TO CONTINUE THE PROCEDURE WITHOUT REPLACING THE SHEATH WITH SOME FLUID LEAKING FOR THE REST OF THE CASE. ABOUT 25CC OF BLOOD LOSS OCCURRED IN TOTAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882717 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION AND A PERICARDIAL EFFUSION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, A VERSACROSS CONNECT FOR FARADRIVE AND VERSACROSS ACCESS SOLUTION KITS WERE SELECTED FOR USE. THE PHYSICIAN HAD DIFFICULTIES GETTING TRANSEPTAL ACCESS USING VERSACROSS CONNECT WHERE TENTING WAS CONTINUOUSLY ANTERIOR. THE PHYSICIAN STRUGGLED TO CLOCK POSTERIOR TO GET RIGHT POSITIONING AND TRIED MULTIPLE TIMES TO ADVANCE RF WIRE OUT AS THE PHYSICIAN BELIEVED WIRE CROSSED WITHOUT APPLYING RADIO FREQUENCY (RF) BUT COULD NOT BE CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) OR FLUOROSCOPY. THE PHYSICIAN REPLACED ALL DEVICES AND TRANSITIONED TO VERSACROSS ACCESS, SHAPED THE DILATOR AND WENT BACK INTO CROSS. ONCE CROSSED WITH THE DILATOR/SHEATH, IT SEEMED TO BE AT ANTERIOR POSITION AND THE WIRE ADVANCED INTO THE APPENDAGE. THE PHYSICIAN MANIPULATED THE SHEATH/WIRE TO ENSURE THE LEFT SUPERIOR VEIN WIRED BEFORE REMOVING THE DILATOR AND WIRE. THE CASE PROCEEDED, AND 50 APPLICATIONS WERE DELIVERED WITH THE FARAWAVE CATHETER ON ALL PULMONARY VEINS SUCCESSFULLY. THE PHYSICIAN THEN REMOVED THE CATHETER TO COMPLETE A POST MAP, AND TOW

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 21454100 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION AND A PERICARDIAL EFFUSION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, A VERSACROSS CONNECT FOR FARADRIVE AND VERSACROSS ACCESS SOLUTION KITS WERE SELECTED FOR USE. THE PHYSICIAN HAD DIFFICULTIES GETTING TRANSEPTAL ACCESS USING VERSACROSS CONNECT WHERE TENTING WAS CONTINUOUSLY ANTERIOR. THE PHYSICIAN STRUGGLED TO CLOCK POSTERIOR TO GET RIGHT POSITIONING AND TRIED MULTIPLE TIMES TO ADVANCE RF WIRE OUT AS THE PHYSICIAN BELIEVED WIRE CROSSED WITHOUT APPLYING RADIO FREQUENCY (RF) BUT COULD NOT BE CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) OR FLUOROSCOPY. THE PHYSICIAN REPLACED ALL DEVICES AND TRANSITIONED TO VERSACROSS ACCESS, SHAPED THE DILATOR AND WENT BACK INTO CROSS. ONCE CROSSED WITH THE DILATOR/SHEATH, IT SEEMED TO BE AT ANTERIOR POSITION AND THE WIRE ADVANCED INTO THE APPENDAGE. THE PHYSICIAN MANIPULATED THE SHEATH/WIRE TO ENSURE THE LEFT SUPERIOR VEIN WIRED BEFORE REMOVING THE DILATOR AND WIRE. THE CASE PROCEEDED, AND 50 APPLICATIONS WERE DELIVERED WITH THE FARAWAVE CATHETER ON ALL PULMONARY VEINS SUCCESSFULLY. THE PHYSICIAN THEN REMOVED THE CATHETER TO COMPLETE A POST MAP, AND TOW

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 21454057 ↗
• MalfunctionFeb 6, 2025Material Frayed; Difficult to Advance; Material Integrity Problem; Physical Resistance/Sticking; Material Frayed; Difficult to Advance; Material Integrity Problem; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) PROCEDURE. DURING INSERTION OF THE VERSACROSS RF WIRE THROUGH THE DILATOR, THE USER MENTIONED THAT THEY HAD DIFFICULTY ADVANCING THE RF WIRE THROUGH DILATOR THAT'S WHEN THEY PULLED THE WIRES ALL THE WAY OUT OF ITS ORIGINAL PACKAGING. UPON FURTHER INSPECTION, THE TIP OF THE RF WIRE HAD FRAYING ELECTRICAL COATING THAT WAS FLAKING OFF OF THE WIRE. A NEW KIT WAS THEN OPENED TO REPLACE THE DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). THE PHYSICIAN HAD A HARD TIME ADVANCING THE RF WIRE, AND WHEN LOOKED AT THE PROXIMAL END OF THE WIRE, IT WAS NOTICED THE INSULATION WAS FLAKING OFF AND STICKING OUT FROM THE CATHETER, GETTING STUCK ON THE DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323398 ↗
• MalfunctionJan 9, 2025Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SENT OUT TO THE CUSTOMER AND THE STERILE PACKAGE WAS COMPROMISED. THE POUCH WAS MISSING. THE DISCOVERY WAS MADE BEFORE THE PROCEDURE AND WAS A DEVICE PULLED FROM THE CURRENT INVENTORY. NO PATIENT COMPLICATIONS WERE REPORTED. NO DAMAGE WAS NOTED ON THE DEVICES. THE DEVICE IS NOT RETURNING FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21119492 ↗
• MalfunctionJan 8, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING THE PROCEDURE, IT WAS MENTIONED THAT THE PHYSICIAN HAD DIFFICULT DURING ATTEMPT TO GO TRANSEPTAL USING VERSACROSS WIRE THROUGH NON-BOSTON SCIENTIFIC VIZIGO SHEATH AND DILATOR). THE BMC RF GENERATOR HAD DELIVERED THE THERAPY, BUT NO BUBBLES WERE NOTED IN LEFT ATRIUM (LA) AND WIRE WAS NOT ABLE TO ADVANCE. IT WAS ATTEMPTED TO REPOSITIONING A FEW TIMES AND ENSURED UNDER FLUORO THAT TIP OF THE VERSACROSS RF WIRE WAS EXPOSED AND IN CONTACT WITH SEPTUM. THUS, THE NEW VERSACROSS KIT WAS USED, AND STILL THE ISSUE PERSISTED. LATER, THE PROCEDURE WAS COMPLETED USING A NRG RF NEEDLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106959 ↗
• MalfunctionJan 8, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING THE PROCEDURE, IT WAS MENTIONED THAT THE PHYSICIAN HAD DIFFICULT DURING ATTEMPT TO GO TRANSEPTAL USING VERSACROSS WIRE THROUGH NON-BOSTON SCIENTIFIC VIZIGO SHEATH AND DILATOR). THE BMC RF GENERATOR HAD DELIVERED THE THERAPY, BUT NO BUBBLES WERE NOTED IN LEFT ATRIUM (LA) AND WIRE WAS NOT ABLE TO ADVANCE. IT WAS ATTEMPTED TO REPOSITIONING A FEW TIMES AND ENSURED UNDER FLUORO THAT TIP OF THE VERSACROSS RF WIRE WAS EXPOSED AND IN CONTACT WITH SEPTUM. THUS, THE NEW VERSACROSS KIT WAS USED, AND STILL THE ISSUE PERSISTED. LATER, THE PROCEDURE WAS COMPLETED USING A NRG RF NEEDLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106941 ↗
• InjuryDec 4, 2024Display or Visual Feedback Problem; Difficult to Remove; Display or Visual Feedback Problem; Difficult to Remove

  IT WAS REPORTED A CARDIAC PERFORATION LEADING TO PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WENT UP WITH THE VERSACROSS RF WIRE WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING ONLY. THE RF WIRE WENT UP WAY HIGH AND COULD NOT BE VISUALIZED ON ICE. THE WIRE WAS ATTEMPTED TO BRING DOWN TO SUPERIOR VENA CAVA (SVC) HOWEVER DIFFICULTY WAS EXPERIENCED. THE PATIENT BLOOD PRESSURE TANKED TO 36/21 AND A LARGE EFFUSION WAS SEEN ON ICE. THREE PERICARDIOCENTESIS KITS WERE USED WITH LITTLE CHANGE TO EFFUSION. THE PATIENT DID GO INTO CARDIAC ARREST AND SUBSEQUENT ACTIONS WERE TAKEN TO STABILIZE THE PATIENT. OPEN STERNOTOMY WAS PERFORMED TO SUTURE THE PERFORATION. A PERFORATION WAS FOUND IN THE RIGHT VENTRICLE AND IT WAS SUTURED AND A PATCH PLACED OVER TO SECURE THE INJURY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PATIENT STABILIZED AFTER CT SURGERY. THE PERFORATION WAS A RESULT OF THE ICE CATHETER GOING THROUGH THE RIGHT VENTRICLE. THE VERSACROSS WIRE DID NOT RELATE TO THE CAUSE OF INCIDENT. THE PHYSICIAN BELIEVES THAT WHILE MA

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

  MAUDE report 20846169 ↗