VersaCross™ Access Solution VXSK0132Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00685447019879), received between Jun 23, 2025 and Aug 3, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac perforation occurred. A left atrial appendage (LAA) closure procedure was being performed, and a VersaCross Access Solution was selected to be used. During the procedure the physicians performed a standalone closure device implantation on a patient with a known baseline pericardial effusion that was confirmed during the pre-procedure imaging assessment. The patient had two pacemaker leads and significant scoliosis, resulting in cardiac rotation and creating challenges with transseptal access. The physician experienced difficulty engaging the fossa ovalis due to the rotated anatomy, and visualization of the optimal tenting location was further complicated by the presence of the pacemaker leads. To improve septal engagement, the physician exchanged for a VersaCross kit to achieve additional curvature. During one of the attempts to drop down onto the septum, the exact tenting location could not be clearly visualized. The physician reported feeling a pop and advanced the wire, however, fluoroscopy showed the wire in an unusual, very posterior position. Recognizing this, the physician immediately withdrew the wire without advancing t

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

  MAUDE report 50124149 ↗
• MalfunctionJul 6, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. WHEN THE PRODUCT BOX WAS RECEIVED FROM SHIPMENT, IT WAS EXTREMELY DAMAGED, THERE WERE HOLES IN THE BOX AND THE STERILE POUCH WAS PUNCTURED, RENDERING THE PRODUCT UNSTERILE. PROCEDURE WAS PERFORMED BY USING A PRODUCT BACKUP, THERE WERE NO PATIENT COMPLICATIONS. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728068 ↗
• MalfunctionFeb 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING THE PULMONARY VEIN ISOLATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT VERSACROSS SHEATH, DILATOR, AND PIGTAIL RF WIRE INSERTED INTO FEMORAL ACCESS SITE, GUIDED UP TO SUPERIOR VENA CAVA (VISUALIZED ON FLUOROSCOPY). PHYSICIAN THEN ATTEMPTED TO RETRACT THE PIGTAIL WIRE INTO THE DILATOR TO BEGIN DROP-DOWN FOR TRANSSEPTAL ACCESS. OBSERVED TIP OF WIRE KNOTTED ON FLUOROSCOPY AND THE PHYSICIAN WAS UNABLE TO RETRACT FULLY INSIDE DILATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW VERSACROSS KIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391897 ↗
• InjuryJan 12, 2026Device Sensing Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. NO EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO GET LEFT ATRIAL ACCESS, HOWEVER THE RF WIRE WAS NOT VISUALIZED IN LEFT ATRIUM AFTER CROSSING. THE PATIENT BLOOD PRESSURE THEN DROPPED AND PERICARDIAL TAMPONADE / FLUID WAS SEEN BUILDING AROUND THE LEFT VENTRICULAR (LV). PATIENT WAS GIVEN MEDICATION AND WAS PREPPED FOR PERICARDIAL TAP. AROUND 600 ML OF DARK RED COLOR FLUID WAS REMOVED. THE PE OCCURRED DURING TRANSSEPTAL CROSSING. THE CASE WAS ABORTED. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. THE PATIENT WAS ADMITTED OVER THE WEEKEND AND EXPECTED TO FULLY RECOVER. A NON-BOSTON SCIENTITIC GUIDEWIRE WAS USED AND SEVERAL EXCHANGES WERE MADE INTO THE SUPERIOR VENA CAVA. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

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

  MAUDE report 24045323 ↗
• MalfunctionDec 10, 2025Deformation Due to Compressive Stress; Air/Gas in Device; Deformation Due to Compressive Stress; Air/Gas in Device

  IT WAS REPORTED THAT DURING A SEPTUM BALLOONING, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE PHYSICIAN SAID THE SHEATH BENT AND WAS SUCKING AIR. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (CONTAMINATED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773806 ↗
• MalfunctionDec 1, 2025Nonstandard Device; Off-Label Use; Material Integrity Problem; Nonstandard Device; Off-Label Use; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION/ POSTERIOR WALL ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. TRANSSEPTAL WAS ACHIEVED WITHOUT ISSUE USING VERSACROSS TRANSSEPTAL SHEATH. THE LEFT ATRIUM PRE-MAP WAS CREATED. VERSACROSS RF PIGTAIL WIRE USED TO EXCHANGE TRANSSEPTAL SHEATH FOR A NON-BOSTON SCIENTIFIC SHEATH. AFTER REMOVING THE NON-BOSTON SCIENTIFIC DILATOR AND PIGTAIL WIRE, PHYSICIAN NOTICED THE END OF PIGTAIL WIRE INSULATIVE COATING HAD SEPARATED FROM THE ACTUAL WIRE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687787 ↗
• InjuryNov 19, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PERICARDIAL EFFUSION (PE) AND ARRHYTHMIA. DURING A DENOVO PULMONARY VEIN ISOLATION AND ABLATION FOR PERSISTENT ATRIAL FIBRILLATION (AFIB) PROCEDURE, A VERSACROSS ACCESS SOLUTION AND FARAWAVE WERE SELECTED FOR USE. THE TRANSSEPTAL APPROACH WAS GUIDED BY FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PRE TEE IMAGES WERE OBTAINED DEMONSTRATING NO EFFUSION. THE VERSACROSS RF WIRE WAS USED WITH A NON-BOSTON SCIENTIFIC SHEATH AND DILATOR. FIRST TRANSSEPTAL TRANSSEPTAL WAS TOO ANTERIOR PER PHYSICIAN AND IT WAS DECIDED TO RESTICK. THE SECOND TRANSSEPTAL WAS MID-MID AND WAS USED FOR PULMONARY VEIN ISOLATION PROCEDURE. THE FARAWAVE CATHETER WAS USED FOR PULMONARY VEIN ISOLATION, POSTERIOR, ANTERIOR, AND LATERAL WALL ABLATION. A POST PROCEDURE HIS-VENTRICULAR (HV) MEASUREMENT WAS RECORDED BY THE FARAWAVE CATHETER IN BASKET POSITION IN RIGHT ATRIUM. AN EFFUSION CHECK WAS DONE AGAIN AFTER FIRST TRANSSEPTAL AND IMMEDIATELY POST PROCEDURE. PATIENT EXPERIENCED A LONG PAUSE DURING A SPONTANEOUS CONVERSION FROM AFIB TO SINUS WITH A SLOW JUNCTIONAL RESPONSE ON THE ANTERIOR WALL ABLATION. POST PROCEDURE THE PATIENT DEVELOPED HYPOTENSION AND A SLOW JUNC

  Patient problems: Arrhythmia; Bradycardia; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23598285 ↗
• MalfunctionNov 5, 2025Signal Artifact/Noise; Failure to Deliver Energy; Failure to Advance; Signal Artifact/Noise; Failure to Deliver Energy; Failure to Advance

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION SELECTED FOR USE. DURING PROCEDURE, IT WAS TRIED TO CROSS THE SEPTUM AND UNABLE TO PROCESS ACROSS THE SEPTUM WHEN ACTIVATED BY THE GENERATOR. THEY WERE NOT AWARE OF THE PROCEDURE AT THAT POINT CROSSING THE SEPTUM. THEREFORE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING DIFFERENT DEVICE, SAME MODEL. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO RETURN FOR ANALYSIS. IT WAS FURTHER REPORTED THAT THERE WAS NO DIFFICULT ANATOMY NOTED DURING THE CASE WHICH MAY HAVE CONTRIBUTED TO THE ISSUE. THERE WAS NO DIFFICULTY/RESISTANCE FELT WHEN TRACKING THE WIRE UP/DROPPING DOWN ONTO THE SEPTUM. ON FLUORO, IT WAS CONFIRMED THAT THE WIRE WAS EXPOSED FROM THE SHEATH 1-3MM. THERE WAS 3 TIMES CROSSING ATTEMPTED. NO ONE REMEMBER WHETHER THERE WAS ERROR CODE OR NOT, BUT IT JUST MADE THE AUDIBLE NOISE IT WASN'T WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480411 ↗
• MalfunctionSep 10, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED 13 AUGUST 2025. IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION DEVICE WAS SELECTED FOR ABLATION PROCEDURE. DURING INSERTION, THE VERSACROSS ACCESS SOLUTION RF WIRE WAS GOT STUCK. THE GUIDEWIRE WAS UNABLE TO FIT INTO THE DILATOR DUE TO A BEND IN THE WIRE THAT WAS CREATED WHEN BEING PUSHED THROUGH DESPITE THE SIZES BEING COMPATIBLE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019923 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A CONCOMITANT ATRIAL FIBRILLATION / LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITHOUT ANY ISSUES REPORTED. A MAPPING GEOMETRY CREATED. THE MAPPING CATHETER FELL OUT OF LEFT ATRIUM TO RIGHT ATRIUM. AT THIS TIME, THE PHYSICIAN NOTED LOW BLOOD PRESSURE AND GLOBAL EFFUSION NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE GLOBAL PE WAS NOTED AFTER TSP WAS COMPLETED. NO, THE VC WAS NOT IN BODY. THE PHYSICIAN PROCEEDED WITH PERICARDIOCENTESIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE COMPLICATION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO FURTHER INFORMATION WAS DISCLOSED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22513212 ↗
• MalfunctionJun 23, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. DURING FEMORAL ACCESS, THE PHYSICIAN PLACED THE VERSACROSS WIRE THROUGH A NON-BOSTON SCIENTIFIC COOK NEEDLE INTO THE FEMORAL VEIN. THE WIRE WOULD NOT ADVANCE AND WHEN RETRACTING THE WIRE BACK THROUGH THE NEEDLE IT WAS NOTED THAT THE COATING OF THE WIRE NEAR THE PIGTAIL WAS DAMAGED FROM THE NEEDLE. THE WIRE WAS REPLACED WITH A WIRE FROM ANOTHER KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309672 ↗