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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00685447011736), received between Jul 13, 2023 and Nov 19, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. THE TRANSEPTAL ACCESS WAS OBTAINED WITHOUT ISSUE AND THE PHYSICIAN LANDED VERSACROSS RF WIRE IN LEFT SUPERIOR PULMONARY VEIN (LSPV) AFTER CROSSING THE SEPTUM. VERSACROSS SHEATH WAS EXCHANGED FOR WATCHMAN TRUSTEER SHEATH AND THE RF WIRE WAS EXCHANGED FOR A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER. THE PIGTAIL CATHETER AND WATCHMAN SHEATH WERE MOVED TO APPENDAGE OSTIUM. WHILE WAITING FOR THE ACT RESULT, ANESTHESIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGER POINTED OUT SMALL FLAPPING PIECE ATTACHED TO THE END OF LSPV WHICH WAS NOT NOTED BY ANYONE DURING PRE IMAGING DURING START OF THE CASE. IT WAS WATCHED FOR SEVERAL MINUTES AS ACT RESULTED 198. THE PHYSICIAN DECIDED IT WAS STABLE, MORE HEPARIN WAS GIVEN, AND PROCEDURE WAS COMPLETED AS USUAL. AFTER WATCHMAN DEVICE WAS EXPLANTED, SHEATH WAS PULLED BACK ACROSS SEPTUM AT WHICH TIME TEE IMAGER AND IMPLANTING PHYSICIAN NOTED OBJECT IN RIGHT ATRIUM ON THE FOSSA. THE PHYSICIAN DECIDED TO PUT WATCHMAN SHEATH UP TO OBJECT AND ASPIRATED IT. THE OBJECT WAS NO LONGER FOUND ON TEE, HOWEVER WHEN THE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23598284 ↗
• MalfunctionOct 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE VERSACROSS SHEATH WAS TAKEN OUT OF PACKAGE STERILE AND FLUSHED. IT WAS THEN ADVANCED INSIDE THE PATIENT (RIGHT ATRIUM) AND CROSSED INTO LEFT ATRIUM WHERE IT WAS NOTED TO HAVE A "CLOT" LIKE IMAGE ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. THE ACTIVATED CLOTTING TIME (ACT) AT THIS TIME WAS GREATER THAN 410 SECONDS. THE PHYSICIAN WENT INTO EMERGENCY PLANNING TO REMOVE THE "CLOT" AND SAFELY REMOVED THE SHEATH. ONCE THE SHEATH WAS OUTSIDE OF THE PATIENT, IT WAS FLUSHED WITH SALINE TO FIND NO CLOTS PRESENT. HOWEVER, THERE WAS A LONG STRING OF "PLASTIC SUBSTANCE" THAT HAD COME FROM THE SHEATH. THE PHYSICIAN FEELS THAT THE "CLOT LIKE SUBSTANCE" ON THE ICE CATHETER WAS THE "PLASTIC STRING-LIKE" PARTICLE. HENCE, THE DEVICE WAS REPLACED WITH VERSACROSS CONNECT KIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. UF/IMPORTER REPORT # (B)(4). IT WAS FURTHER CONFIRMED THERE WAS NO DAMAGE TO THE SHEATH OR PACKAGING. THE ISSUE WAS IDENTIFIED AFTER TRANSSEPTAL ACCESS HAD BEEN OBT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560117 ↗
• MalfunctionOct 9, 2024Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A PULSE FIELD ABLATION PROCEDURE. DURING THE PROCEDURE, THE USER MENTIONED THE TIP OF THE DILATOR WAS NOTED TO BE DEFECTIVE, LOOKING TO BE FLATTENED CAUSING DIFFICULTY DURING INSERTION/ADVANCE IT. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS AVAILABLE FOR RETURN. THE DAMAGE WAS SEEN AFTER INSERTING THE DILATOR INTO THE SHEATH. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410028 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERFORATION, A PERICARDIAL EFFUSION AND A CARDIAC TAMPONADE OCCURRED. DURING AN ATRIAL FIBRILLATION ABLATION, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. FIRST, TRANSSEPTAL PUNCTURE FOR THE PROCEDURE WAS ACHIEVED USING A VERSACROSS SYSTEM (WITH NO ISSUES REPORTED) AND THEN A NON-BOSTON SCIENTIFIC MAPPING CATHETER WAS USED TO MAP THE PATIENT'S LEFT ATRIUM. THE ABLATION PORTION OF THE PROCEDURE WAS COMPLETED USING A FARAWAVE PFA CATHETER. NO COMPLICATIONS OR ISSUES WERE NOTED DURING THE PROCEDURE; HOWEVER, AFTER THE CATHETERS HAD BEEN REMOVED FROM THE BODY AND THE SHEATH HAD BEEN PULLED BACK INTO THE RIGHT ATRIUM THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS CONFIRMED THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) TO BE SURROUNDED RIGHT AND LEFT VENTRICLES, AND PERICARDIOCENTESIS WAS PERFORMED. AT THIS POINT, FLUOROSCOPY REVEALED CARDIAC TAMPONADE. THE DRAINED BLOOD WAS FOUND TO BE ARTERIAL BLOOD, AND THE PHYSICIAN BELIEVES A PERFORATION OCCURRED IN THE LEFT ATRIUM. THE PATIENT STABILIZED AND THE PROCEDURE WAS THEN COMPLETED. IT WAS EXPECTED THE PATIENT TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THERE IS NO REASON TO BELIEVE

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

  MAUDE report 20287564 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED, AND THE PROCEDURE WAS CANCELLED. IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION. THE TRANSSEPTAL PUNCTURE WAS PERFORMED SUCCESSFULLY, AND PULMONARY VEIN ISOLATION CONTINUED AFTERWARDS WITH THE FARAWAVE CATHETER. UPON MOVING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER TO VIEW ANOTHER HEART STRUCTURE A SMALL PERICARDIAL EFFUSION WAS OBSERVED THAT WAS NOT NOTED PRIOR, LOCATED MORE ON THE RIGHT SIDE OF THE HEART. THE FARAWAVE CATHETER WAS IN THE LEFT ATRIUM (LA) AT THE TIME THE EFFUSION WAS LOCATED. THE PATIENT'S VITAL WERE STABLE. PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE WAS CANCELLED BEFORE PERFORMING THE PLANNED POSTERIOR WALL ABLATION. THE PATIENT WAS EXPECTED A FULLY RECOVER AND LATER DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IN THE PHYSICIAN'S OPINION, IT IS POSSIBLE THAT THE PE OCCURRED EITHER DURING TRANSSEPTAL ACCESS OR ALONG WITH A NON-BOSTON SCIENTIFIC BIOSENSE WEBSTER "WEBSTER" CS CATHETER. IMAGING WAS USED TO CONFIRM THE EFFUSION. NO MALFUNCTION WAS REPORTED FOR THE VERSACROSS DEVICES.

  Patient problems: Pericardial Effusion

  MAUDE report 20251188 ↗
• InjuryAug 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A CARDIAC PERFORATION, PERICARDIAL EFFUSION FOLLOWED BY CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A FARAPULSE PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS ATTEMPTING FOR TRANSSEPTAL, AND THE RADIO FREQUENCY (RF) WAS APPLIED THREE TIMES IN ORDER TO NOTE THE RF BUBBLES IN THE LEFT ATRIUM (LA) WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE. THERE WAS A RESISTANCE FELT WITH THE VERSACROSS RF WIRE. ONCE THE WIRE WAS IN THE LA, IT WAS NOTED TO BE KINKED. THUS, A PROTRACK WIRE WAS OPENED AND INSERTED TO EXCHANGE FOR THE FARADRIVE CLEAR SHEATH. ONCE THE FARADRIVE CATHETER WAS INSERTED INTO THE HEART, A SIGNIFICANT DROP IN BLOOD PRESSURE WAS NOTED AND A PERICARDIAL EFFUSION WAS NOTED ON ICE, LOCATED AROUND THE RIGHT VENTRICLE. THE PROCEDURE WAS ABORTED AT THIS POINT, AND AN OPEN-HEART SURGERY WAS PERFORMED TO CLOSE A PUNCTURE TO THE RIGHT ATRIUM. THE SURGEON NOTED A PUNCTURE IN THE RIGHT ATRIUM WHEN THE CHEST WAS OPEN. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE AND NOTED TO BE DOING WELL AFTER THE SURGERY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE ANATOMY WAS NOT DI

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

  MAUDE report 19973586 ↗
• InjuryAug 13, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED A CARDIAC PERFORATION, PERICARDIAL EFFUSION FOLLOWED BY CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A FARAPULSE PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS ATTEMPTING FOR TRANSSEPTAL, AND THE RADIO FREQUENCY (RF) WAS APPLIED THREE TIMES IN ORDER TO NOTE THE RF BUBBLES IN THE LEFT ATRIUM (LA) WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE. THERE WAS A RESISTANCE FELT WITH THE VERSACROSS RF WIRE. ONCE THE WIRE WAS IN THE LA, IT WAS NOTED TO BE KINKED. THUS, A PROTRACK WIRE WAS OPENED AND INSERTED TO EXCHANGE FOR THE FARADRIVE CLEAR SHEATH. ONCE THE FARADRIVE CATHETER WAS INSERTED INTO THE HEART, A SIGNIFICANT DROP IN BLOOD PRESSURE WAS NOTED AND A PERICARDIAL EFFUSION WAS NOTED ON ICE, LOCATED AROUND THE RIGHT VENTRICLE. THE PROCEDURE WAS ABORTED AT THIS POINT, AND AN OPEN-HEART SURGERY WAS PERFORMED TO CLOSE A PUNCTURE TO THE RIGHT ATRIUM. THE SURGEON NOTED A PUNCTURE IN THE RIGHT ATRIUM WHEN THE CHEST WAS OPEN. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE AND NOTED TO BE DOING WELL AFTER THE SURGERY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE ANATOMY WAS NOT DI

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

  MAUDE report 19973579 ↗
• MalfunctionMay 17, 2024Defective Device; Device-Device Incompatibility; Physical Resistance/Sticking; Defective Device; Device-Device Incompatibility; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A PULMONARY VEIN ISOLATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THE MECHANICAL GUIDEWIRE GOT STUCK IN THE DILATOR, HOWEVER, ITS BELIEVED THAT THE MGW WAS NOT EXPOSED TO THE PATIENT AT THE TIME. THE DILATOR AND GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT AND REPLACED. IT WAS ALSO NOTICED THAT THE GUIDEWIRE OUTER COIL BEGAN SEPARATING FROM THE CORE WIRE DURING USE. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT HAS BEEN CONFIRMED THAT NO ISSUES WERE NOTED WITH THE GUIDEWIRE OR DILATOR PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345242 ↗
• MalfunctionMay 7, 2024Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN INSERTED THE MECHANICAL J-WIRE INTO THE SUPERIOR VENA CAVA (SVC) AND THEN THE VERSACROSS SHEATH AND DILATOR OVER IT. WHEN THE PHYSICIAN WAS ADVANCING THE MECHANICAL GUIDEWIRE, THERE WAS NO ISSUES, HOWEVER WHEN IT WAS TRIED TO PULL THE SHEATH INTO THE DILATOR, THE MECHANICAL GUIDEWIRE WAS STUCK INSIDE THE DILATOR. WHEN TRIED TO PUSH THE MECHANICAL GUIDEWIRE FORWARD AND PULL IT BACK, IT WAS NOTED THAT IT WAS STUCK. THE PHYSICIAN THEN REMOVED THE VERSACROSS SHEATH AND DILATOR AND THE WIRE OUT OF THE BODY. A NEW VERSACROSS KIT WAS OPENED, AND NO ISSUES WERE NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER CONFIRMED THAT THE MECHANICAL GUIDEWIRE WAS ABOUT 3 INCHES PROTRUDING OUT OF THE TIP OF THE DILATOR WHEN IT GOT STUCK. THE GUIDEWIRE REMAINED IN ONE PIECE. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258205 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION CRYO. AN AIR EMBOLISM WAS REPORTED. THE VERSACROSS DEVICES WERE PROPERLY PREPPED BEFORE THE PROCEDURE. THE VERSACROSS SHEATH AND MECHANICAL GUIDEWIRE WERE INSERTED OVER THE GUIDEWIRE INSIDE THE BODY. THE GUIDEWIRE WAS EXCHANGED FOR THE VERSACROSS RF WIRE. THE VERSACROSS RF WIRE CROSSED THE SEPTUM WITHOUT THE USE OF RADIO FREQUENCY (THE RADIO FREQUENCY WAS NOT DELIVERED). THE VERSACROSS SHEATH AND THE RF WIRE WERE REMOVED FROM THE BODY. IT WAS FLUSHED AND ASPIRATED THE SHEATH. A NON-BOSTON SCIENTIFIC BSW LASSO DECAPOLAR STEERABLE CATHETER WAS INSERTED THROUGH THE VERSACROSS SHEATH SO THAT THE LASSO WAS INSIDE THE BODY, BUT HAD NOT YET ENTERED THE HEART. THE SHEATH WAS FLUSHED AND ASPIRATED AGAIN. THE PHYSICIAN NOTICED BUBBLES WHEN ASPIRATING. THE LASSO CATHETER WAS ADVANCED INTO THE LEFT ATRIUM. WHILE INSERTING THE BSW LASSO DECAPOLAR CATHETER, THE PATIENT THEN HAD AN ST SEGMENT ELEVATION ON THE ECG (ELECTROCARDIOGRAM). IT WAS WAITED ABOUT 2 MINUTES FOR THE ST SEGMENT ELEVATION TO RETURN TO BASELINE. THE PROCEDURE CONTINUED AS NORMAL AND IT WAS COMPLETED SUCCESSFULLY. THE DEVICE

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 18604860 ↗
• InjuryJan 30, 2024Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION CRYO. AN AIR EMBOLISM WAS REPORTED. THE VERSACROSS DEVICES WERE PROPERLY PREPPED BEFORE THE PROCEDURE. THE VERSACROSS SHEATH AND MECHANICAL GUIDEWIRE WERE INSERTED OVER THE GUIDEWIRE INSIDE THE BODY. THE GUIDEWIRE WAS EXCHANGED FOR THE VERSACROSS RF WIRE. THE VERSACROSS RF WIRE CROSSED THE SEPTUM WITHOUT THE USE OF RADIO FREQUENCY (THE RADIO FREQUENCY WAS NOT DELIVERED). THE VERSACROSS SHEATH AND THE RF WIRE WERE REMOVED FROM THE BODY. IT WAS FLUSHED AND ASPIRATED THE SHEATH. A NON-BOSTON SCIENTIFIC BSW LASSO DECAPOLAR STEERABLE CATHETER WAS INSERTED THROUGH THE VERSACROSS SHEATH SO THAT THE LASSO WAS INSIDE THE BODY, BUT HAD NOT YET ENTERED THE HEART. THE SHEATH WAS FLUSHED AND ASPIRATED AGAIN. THE PHYSICIAN NOTICED BUBBLES WHEN ASPIRATING. THE LASSO CATHETER WAS ADVANCED INTO THE LEFT ATRIUM. WHILE INSERTING THE BSW LASSO DECAPOLAR CATHETER, THE PATIENT THEN HAD AN ST SEGMENT ELEVATION ON THE ECG (ELECTROCARDIOGRAM). IT WAS WAITED ABOUT 2 MINUTES FOR THE ST SEGMENT ELEVATION TO RETURN TO BASELINE. THE PROCEDURE CONTINUED AS NORMAL AND IT WAS COMPLETED SUCCESSFULLY. THE DEVICE

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 18604851 ↗
• MalfunctionNov 3, 2023Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS ACCESS SOLUTION KIT HAS BEEN SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THE SHEATH HAD A STRING-LIKE FILAMENT IN IT WHEN IT WAS PULLED OUT OF THE BODY. THEY ALSO REPORTED EXPERIENCING FRICTION AS THEY ADVANCED THE DILATOR OVER THE WIRE AND THEY WERE NOT SURE IF IT WAS THE NON-BOSTON SCIENTIFIC PENTARAY DEVICE SCRATCHING AS WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME KIT AS THE ISSUE WAS NOTED AT THE END OF THE PROCEDURE. NO DAMAGE WAS NOTED UPON REMOVAL FROM THE PACKAGING. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS. 02NOV2023: GFE RESPONSE RECEIVED - IT HAS BEEN FURTHER MENTIONED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME KIT AS THE ISSUE WAS NOTED AT THE END OF THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE UPON REMOVAL FROM THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070008 ↗
• MalfunctionJul 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. DURING THE PROCEDURE A LEAK FROM HEMOSTASIS VALVE WAS NOTED. NO FURTHER DETAILS WERE PROVIDED. THE PROCEDURE AND DEVICE OUTCOME DETAILS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316219 ↗