VersaCross Connect Access Solution for FARADRIVE VXAK0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00685447019060), received between Apr 23, 2024 and May 14, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE, ACCESS WAS OBTAINED AND AN 8FR SHEATH WAS PLACED FOR GUIDEWIRE ACCESS; HOWEVER, WHEN ATTEMPTING TO ADVANCE THE VERSACROSS DILATOR AND FARADRIVE SHEATH OVER THE GUIDEWIRE, THE SYSTEM BECAME STUCK UPON ENTERING THE GROIN, AND THE DILATOR TIP WAS DEFORMED DUE TO PATIENT ANATOMY, LEADING TO REPLACEMENT OF THE DILATOR WITH A NEW VERSACROSS CONNECT KIT. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO RETURN FOR LABORATORY ANALYSIS SINCE IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167423 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE WAS SELECTED FOR USE. THE PHYSICIAN OBTAINED ACCESS AND INSERTED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND CORONARY SINUS (CS) CATHETER INTO THE HEART. THERE WAS A TRACE EFFUSION NOTED AT BASELINE. THE PATIENT CAME IN IN SOME SORT OF FLUTTER. THE PHYSICIAN THEN SET UP TO GO ACROSS FOR TRANSSEPTAL USING VERSACROSS CONNECT AND FARADRIVE SHEATH. THE INITIAL TRANSSEPTAL PUNCTURE (TSP) SITE WAS TOO LOW SO THE PHYSICIAN MOVED IT UP A BIT ON THE SEPTUM AND WENT ACROSS WITH THE WIRE ACROSS INTO THE LEFT ATRIUM (LA). AS THE PHYSICIAN WAS PUSHING THE CONNECT SYSTEM ACROSS INTO THE LEFT ATRIUM, AN UNKNOWN STRUCTURE WAS NOTED ON ICE. THE PHYSICIAN THEN WENT TO CHECK FOR AN EFFUSION AND NOTICED THE TRACE EFFUSION GOT LARGER. THE PHYSICIAN REQUESTED TO ADMINISTER PROTAMINE, PREPPED A PERICARDIOCENTESIS KIT, AND PROCEEDED TO TAP THE PATIENT. AT THIS POINT THE PATIENTS HEART RATE HAD INCREASED TO RIGHT BELOW 200 AND BLOOD PRESSURE GOT LOWER. THE PHYSICIAN SUCCESSFULLY REMOVED ALMOST 900CC OF BLOOD AND PLACED A DRAIN FOR THE PATIE

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 24420890 ↗
• InjuryNov 5, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING AN ATRIAL FIBRILLATION PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE AND A FARADRIVE STEERABLE SHEATH CLEAR WERE SELECTED FOR USE. THE PHYSICIAN WENT TO DO TRANSEPTAL AS USUAL. THE VERSACROSS WIRE WAS ADVANCED TO SUPERIOR VENA CAVA (SVC) AND THEN FARADRIVE. THE PHYSICIAN CONFIRMED IT WAS A GOOD THIN MID MID STICK, ANTERIOR WAS TOO THICK AND PROCEEDED TO RADIO FREQUENCY FOR TRANSEPTAL. IT WAS NOTED RIGHT AWAY THAT THE WIRE POSITIONING WAS VERY OFF AND APPEARED TO BE IN PERICARDIAL SPACE OR AORTA. TRANSEPTAL ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) LOOKED VERY GOOD AND NOT TOO POSTERIOR OR ANTERIOR. THE PHYSICIAN FELT GOOD WITH POSITIONING AND THEN ADVANCED THE SHEATH ACROSS USING ICE. THE PHYSICIAN WAS UNABLE TO ASPIRATE BACK ANY BLOOD AND AT THE SAME TIME ANESTHESIA STATED THERE WAS A SHARP DROP IN BLOOD PRESSURE. THE FARADRIVE WAS PULLED BACK INTO RIGHT ATRIUM AND PERFORMED PERICARDIOCENTESIS. HOWEVER, THE PHYSICIAN COULD NOT GET THE DRAIN IN. THERE WAS NO DIFFICULTIES VISUALIZING VERSACROSS WIRE AND 1 MM TIP WAS TENTING ON SEPTUM. THE PHYSICIAN DID STATE

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

  MAUDE report 23477213 ↗
• MalfunctionJan 13, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT FOR FARADRIVE WAS SELECTED FOR USE FOR ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, IT WAS MENTIONED THAT WHEN THE PHYSICIAN WAS ACCIDENTALLY INSERTING THE VERSACROSS RF WIRE INTO A NON-BOSTON SCIENTIFIC INTRODUCER NEEDLE (COOK), THE RF WIRE BECAME STRIPPED. A NEW VERSACROSS KIT WAS THEN OPENED TO REPLACE THE WIRE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE USE OF THE INTRODUCER NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE PHYSICIAN WAS UNAWARE THAT THE VERSACROSS RF WIRE CANNOT BE INSERTED INTO A COOK INTRODUCER NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138183 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A THROMBUS WAS NOTED. DURING ATRIAL FIBRILLATION AND TYPICAL ATRIAL FLUTTER ABLATION PROCEDURE, A VERSACROSS; CONNECT FOR FARADRIVE KIT WAS SELECTED FOR USE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED PRIOR TO PROCEDURE TO RULE OUT PRESENCE OF LEFT ATRIAL APPENDAGE (LAA) THROMBUS HOWEVER THE PHYSICIAN DID NOT EXAMINE THE RIGHT ATRIUM FOR PRESENCE OF THROMBUS. NO THROMBUS WAS NOTED IN THE LAA. THE FEMORAL ACCESS WAS OBTAINED. THREE SHORT SHEATHS WERE INTRODUCED OVER SHORT WIRES. THEN AN 8FR SHORT SHEATH WAS EXCHANGED FOR THE FARADRIVE SHEATH OVER THE VERSACROSS RF WIRE. UPON APPROACHING THE INTRA ATRIAL SEPTUM, A THROMBUS WAS NOTED ON THE TIP OF THE VERSACROSS CONNECT DILATOR AND/OR FARADRIVE SHEATH. THE FARADRIVE SHEATH AND VERSACROSS WIRE WERE REMOVED FROM THE BODY. THE PATIENT WAS THEN ANTICOAGULATED TO ACHIEVE AN ACTIVATED CLOTTING TIME (ACT) OF GREATER THAN 350SEC. THE TRANSSEPTAL PUNCTURE WAS PERFORMED USING THE ORIGINAL SHEATH, HOWEVER A NEW VERSACROSS WIRE AS ORIGINAL ONE WAS MISTAKENLY BENT BY THE SCRUB TECH UPON REMOVING FROM THE BODY. AN ACT OF GREATER THAN 375 SEC WAS MAINTAINED DURING THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS THEN COMPL

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21004087 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERFORATION AND PERICARDIAL EFFUSION (PE) HAS OCCURRED. IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR USE A PFA PROCEDURE. BEFORE ABLATION, IT WAS FOUND THAT THE PATIENT HAD A BASELINE EFFUSION. THE CTI WAS ABLATED WITH THE FARAWAVE CATHETER OFF-LABELED, WITHOUT COMPLICATIONS. THEN, THE PHYSICIAN PERFORMED A TRANSSEPTAL PUNCTURE AND ADVANCED THE CATHETER INTO THE LEFT ATRIUM TO COMPLETE THE PULMONARY VEIN ISOLATION SUCCESSFULLY. AFTER COMPLETING THE ABLATION, THE PHYSICIAN LOOKED AT THE EXISTING EFFUSION AND NOTICED THAT IT WAS INCREASING (POSTERIOR). A PERICARDIOCENTESIS WAS PERFORMED AND A DRAIN WAS PLACED. THE PATIENT WAS HOSPITALIZED BEYOND STANDARD OF CARE AND WAS DOING WELL AND GETTING THEIR CHEST TUBE REMOVED SOMETIME ON THE LAST WEEK OF OCTOBER. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED. IN THE PHYSICIAN'S OPINION, ANY OF THE BOSTIN SCIENTIFIC PRODUCTS USED DURING THE PROCEDURE CONTRIBUTED TO THIS ADVERSE EVENT. A PERFORATION HAD HAPPENED. NO OTHER ISSUES WERE REPORTED.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20589206 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERFORATION, PERICARDIAL EFFUSION AND BRADYCARDIC OCCURRED. DURING A FARAPULSE PULMONARY VEIN ISOLATION (PVI) PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE KIT WAS SELECTED FOR USE. THE PROCEDURE WAS COMPLETED USING THE FARADRIVE SHEATH, FARAWAVE ABLATION CATHETER AND VERSACROSS CONNECT. AT SOME POINT DURING PROCEDURE, THE PATIENT WAS VERY BRADYCARDIC (- 30 BPM). BUT NO EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND PVI PROCEDURE WENT UNREMARKABLE. THE VERSACROSS DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THEN DURING CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE INDICATED FOR TYPICAL RIGHT ATRIAL FLUTTER, A NON-BOSTON SCIENTIFIC RF ABLATION CATHETER WITH THE VIZIGO SHEATH TO ABLATE THE CTI WERE USED. DURING THE LAST RF APPLICATION, THE PHYSICIAN FELT A 'POP'. AT THAT POINT, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. A PERICARDIAL EFFUSION WAS NOTED ON ICE. A CONTRAST INJECTION WAS ATTEMPTED TO AID IN VISUALIZATION OF THE PERFORATION OCCURRED, BUT THE FINDINGS WERE INCONCLUSIVE. THE PATIENT WAS SUBSEQUENTLY TAPPED MORE THAN THREE TIMES TO DRAIN THE PERICARDIAL SPACE AND WAS INTUBATED AND RECEIVED BLOOD PRODUCT TRANSFUSION. THE PATIENT WAS CONSULTED BY CA

  Patient problems: Bradycardia; Cardiac Perforation; Pericardial Effusion

  MAUDE report 20401236 ↗
• MalfunctionSep 10, 2024Defective Device; Defective Device

  IT WAS REPORTED DURING A PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS CONNECT FOR FARADRIVE KIT WAS SELECTED FOR USE. THE VERSACROSS DILATOR WAS PREPPED TO BE INSERTED IN FARADRIVE SHEATH. WHEN THE DILATOR WAS IN THE SHEATH AND WAS ABOUT TO HAVE THE WIRE LOADED THROUGH THE DILATOR, THE PHYSICIAN NOTICED THAT THE TIP OF THE DILATOR WAS DEFECTIVE. THE DEFECT WAS DESCRIBED AS 'A LITTLE MELTED OR THAT IT HAS EXTRA PLASTIC TO ONE SIDE OF THE TIP'. HENCE TO RESOLVE THE ISSUE, BOTH THE SHEATH AND DILATOR WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. HOWEVER, ANALYSIS REVEALED THAT THE DILATOR TIP WAS DEFECTIVE AND DEFORMED, ALONG WITH A SLITTING OF DILATOR TIP, AN ANGLED CUT HAS CREATED A 'FLAP' OF MATERIAL ON OUTSIDE SURFACE AND THE TIP HAS NOT OVALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180475 ↗
• InjuryAug 6, 2024Display or Visual Feedback Problem; Positioning Problem; Display or Visual Feedback Problem; Positioning 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 CONNECT FOR FARADRIVE WAS SELECTED FOR USE. THE PHYSICIAN GAINED FEMORAL ACCESS AND INSERTED A NON-BOSTON SCIENTIFIC INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND SOUND FAM CATHETERS. THEN, THE VERSACROSS RF WIRE FOLLOWED BY THE VERSACROSS DILATOR AND FARADRIVE SHEATH WAS INSERTED. WHEN THE DEVICES WERE DROPPED DOWN FROM SUPERIOR VENA CAVA (SVC) TO RIGHT ATRIUM (RA), THE PHYSICIAN NOTICED SOME UNUSUAL TACTILE FEEDBACK. ON THE FLUOROSCOPY, IT WAS NOTED THE VERSACROSS RF WIRE WAS IN RA BUT COULD NOT BE VISUALIZED ON ICE. THE PHYSICIAN PULLED EVERYTHING BACK TO RE-POSITION INTO SVC BUT WAS UNABLE TO GET THE WIRE BACK OUT. THEN, THE PHYSICIAN SWEPT THROUGH ATRIA WITH ICE AND NOTICED A GROWING EFFUSION. THE PROCEDURE WAS ABORTED, AND EFFUSION WAS BEING MONITORED, WHICH GREW CONTINUOUSLY. THE PATIENT WAS GIVEN ANTICOAGULANT REVERSAL AGENTS AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE, SPENT THE NIGHT FOLLOWING THE CASE BUT HAS RECOVERED. THE DEVICE IS NOT EXPECTED

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19918739 ↗
• InjuryAug 6, 2024Display or Visual Feedback Problem; Difficult to Advance; Positioning Problem; Display or Visual Feedback Problem; Difficult to Advance; Positioning 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 CONNECT FOR FARADRIVE WAS SELECTED FOR USE. THE PHYSICIAN GAINED FEMORAL ACCESS AND INSERTED A NON-BOSTON SCIENTIFIC INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND SOUND FAM CATHETERS. THEN, THE VERSACROSS RF WIRE FOLLOWED BY THE VERSACROSS DILATOR AND FARADRIVE SHEATH WAS INSERTED. WHEN THE DEVICES WERE DROPPED DOWN FROM SUPERIOR VENA CAVA (SVC) TO RIGHT ATRIUM (RA), THE PHYSICIAN NOTICED SOME UNUSUAL TACTILE FEEDBACK. ON THE FLUOROSCOPY, IT WAS NOTED THE VERSACROSS RF WIRE WAS IN RA BUT COULD NOT BE VISUALIZED ON ICE. THE PHYSICIAN PULLED EVERYTHING BACK TO RE-POSITION INTO SVC BUT WAS UNABLE TO GET THE WIRE BACK OUT. THEN, THE PHYSICIAN SWEPT THROUGH ATRIA WITH ICE AND NOTICED A GROWING EFFUSION. THE PROCEDURE WAS ABORTED, AND EFFUSION WAS BEING MONITORED, WHICH GREW CONTINUOUSLY. THE PATIENT WAS GIVEN ANTICOAGULANT REVERSAL AGENTS AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE, SPENT THE NIGHT FOLLOWING THE CASE BUT HAS RECOVERED. THE DEVICE IS NOT EXPECTED

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19918735 ↗
• MalfunctionJul 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS PERFORMING TRANSSEPTAL PUNCTURE AND WHEN ADVANCING THE VERSACROSS J-WIRE ACROSS THE SEPTUM, THE J-WIRE COULD NOT BE VISUALIZED WHETHER IT WAS IN THE LEFT ATRIUM USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. THERE WERE MULTIPLE VIEWS OF ICE ATTEMPTED WITH NO BETTER VISUALIZATION OF J-WIRE TO CONFIRM TRANSSEPTAL PUNCTURE WAS SUCCESSFUL. HENCE TO RESOLVE THE ISSUE, ANOTHER VERSACROSS CONNECT KIT WITH PIGTAIL RF WIRE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740298 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC PERFORATION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND BLOOD LOSS OCCURRED. THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A VERSACROSS CONNECT KIT FOR FARADRIVE (J-WIRE VERSION) WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE (TSP) WAS COMPLETED WITH NO ISSUES. HOWEVER, IT MAY HAD BEEN POSSIBLE THAT THE RADIO FREQUENCY (RF) WAS DELIVERED INADVERTENTLY AFTER THE TRANSSEPTAL WIRE CROSSED INTO THE LEFT ATRIUM. THEN, A NON-BOSTON SCIENTIFIC MAPPING CATHETER (PENTARAY) WAS INSERTED, AND A LEFT ATRIAL GEOMETRY COLLECTED WITH NO ISSUES. THE FARAWAVE WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE (MERIT) WERE INSERTED. THE TEAM UTILIZED A MAPPING SYSTEM (CARTO) AND VISUALIZATION TOOLS TO BE ABLE TO APPROXIMATE THE GUIDE WIRE LOCATION FLUORO-LESS. THE LEFT PULMONARY VEINS WERE ABLATED WITHOUT ANY ISSUE, HOWEVER AFTERWARDS ANESTHETIST DETECTED A DROP IN BLOOD PRESSURE. THE OPERATING PHYSICIAN DID A VIEW OF THE HEART WITH INTRACARDIAC ECHO (ICE) AND IMMEDIATELY NOTICED A PERICARDIAL EFFUSION. IMMEDIATE INTERVENTIONS WERE PERFORMED TO RELIEVE BLOOD DRAINAGE INTO THE PERICARDIAL SPACE, INCLUDING PERICARDIOCENTESIS WHERE SEVERAL HU

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19164558 ↗