VersaCross Steerable Access Solution VSTK0016 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00685447012078), received between Mar 31, 2023 and Oct 3, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION KIT HAS BEEN SELECTED FOR USE FOR A WATCHMAN FLX PROCEDURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS FRONTLOADING AND ADVANCING THE VERSACROSS RF WIRE INTO THE VERSACROSS DILATOR AND STEERABLE SHEATH, IT FELT TIGHT AND DIFFICULTY TO ADVANCE IT, THUS HAD TO APPLY EXCESSIVE FORCE. THEREFORE, A NEW WIRE WAS REQUESTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT RETURNING AS IT WAS DISPOSED IN THE FACILITY. ONCE THE VERSACROSS RF WIRE WAS REMOVED, IT WAS NOTED TO BE BEND/KINK, MOST LIKELY DUE TO THE FORWARD PRESSURE TO ADVANCE IT, WHEN IT WAS FELT TO BE STUCK. NO ISSUES WERE NOTED WHEN WITHDRAWING THE VERSACROSS RF WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359524 ↗
• MalfunctionSep 24, 2024Material Perforation; Device-Device Incompatibility; Material Perforation; Device-Device Incompatibility

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING PROCEDURE, A NON-BOSTON SCIENTIFIC DECAPOLAR STJ INQUIRY CATHETER WAS INSERTED INTO THE VERSACRSOSS SHEATH, PLACED INTO THE CORONARY SINUS, THEN THE INQUIRY CATHETER WAS REMOVED FROM THE SHEATH. BLOOD WAS ASPIRATED FROM THE CORONARY SINUS FROM THE VERSACROSS SHEATH, AND IT WAS RETRACTED FROM THE CORONARY SINUS AND LEFT IN THE RIGHT ATRIUM. THUS, THE NON-BOSTON SCIENTIFIC OCTORAY WAS INSERTED INTO THE VERSACROSS SHEATH TO CREATE AN ELECTROANATOMICAL MAP OF THE RIGHT ATRIUM, AND ONCE IT WAS REMOVED FROM THE VERSACROSS SHEATH, A GRAY FILAMENT WAS REMOVED FROM THE VALVE OF THE VERSACROSS SHEATH. BOTH DEVICES WERE THEN INSPECTED, AND NO DAMAGE WERE NOTED TO EITHER. THEREFORE, THE TRANSSEPTAL WAS ACHIEVED ACROSS TO THE LEFT ATRIUM AND THE VERSACROSS RF WIRE WAS EXCHANGED FOR THE OCTORAY AND AN ELECTROANATOMICAL MAP WAS CREATED OF THE LEFT ATRIUM. ONCE THE OCTORAY WAS REMOVED FROM THE VERSACFOSS SHEATH, ANOTHER GRAY-FILAMENT LIKE STRUCTURE WAS REMOVED FROM THE VALVE OF THE VERSACROSS SHEATH. AGAIN, BOTH DEVICES WERE INSPECTED AND NO ISSUES WERE NOTED ON THEM. THE VERSACROSS WAS EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291710 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance

  IT HAS BEEN REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY EXPERIENCED DIFFICULTY ADVANCING THE DILATOR/SHEATH OVER THE GUIDEWIRE. AT A CERTAIN POINT, THE DILATOR WOULD NOT ADVANCE ANY FURTHER AND COULD ALSO NOT BE WITHDRAWN WITHOUT SIGNIFICANT RESISTANCE. THE DILATOR AND GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT AND A NEW KIT WAS USED (DIFFERENT DEVICE, SAME MODEL). THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN AS IT WAS RETAINED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140267 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. A PERFORATION AND HEMATOMA WAS NOTED AROUND THE AORTA AND PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A FIRST TRANSSEPTAL PUNCTURE WAS DONE (POSTERIOR AND INFERIOR) AND CONSIDERED NOT THE IDEAL POSITION, THEN THE VERSACROSS RF WIRE AND SHEATH WERE REMOVED FROM THE LEFT ATRIUM AND RE-POSITIONED AGAIN FOR A SECOND TRANSSEPTAL THAT WAS COMPLETED AND CONSIDERED TOO ANTERIOR (RADIO FREQUENCY WAS DELIVERED). THUS, AFTER THE SECOND TRANSSEPTAL, THE VERSACROSS RF WIRE WAS NOT SEEN (TRANSESOPHAGEAL ECHOCARDIOGRAM - TEE) IN THE LEFT ATRIUM, THUS IT WAS PULLED BACK INTO RIGHT ATRIUM. ONCE IT WAS DETERMINED THE VERSACROSS WIRE WAS NOT VISIBLE IN THE LEFT ATRIUM, THE VERSACROSS SHEATH WAS NOT ADVANCED INTO THE LEFT ATRIUM (IT STAYED ON THE RIGHT SIDE). THEN, THE LOCATION OF THE VERSACROSS RF WIRE AND THE PATIENT CONDITION/STABILITY WERE REASSESSED. ALL PATIENTS VITALS WERE STABLE. ABOUT 15 MINUTES AFTER THE TRANSSEPTAL PUNCTURE, THERE WAS A THOUGHT OF POTENTIAL HEMATOMA AND A RESULTING DROP IN BLOOD PRESSURE. THIS TURNED OUT TO BE FALSE AND THE DROP OF BLOOD PRESSURE WAS MOST LIKELY DUE TO PROTAMINE INFUSION. N

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 18074279 ↗
• InjuryNov 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE. A PERFORATION AND HEMATOMA WAS NOTED AROUND THE AORTA AND PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A FIRST TRANSSEPTAL PUNCTURE WAS DONE (POSTERIOR AND INFERIOR) AND CONSIDERED NOT THE IDEAL POSITION, THEN THE VERSACROSS RF WIRE AND SHEATH WERE REMOVED FROM THE LEFT ATRIUM AND RE-POSITIONED AGAIN FOR A SECOND TRANSSEPTAL THAT WAS COMPLETED AND CONSIDERED TOO ANTERIOR (RADIO FREQUENCY WAS DELIVERED). THUS, AFTER THE SECOND TRANSSEPTAL, THE VERSACROSS RF WIRE WAS NOT SEEN (TRANSESOPHAGEAL ECHOCARDIOGRAM - TEE) IN THE LEFT ATRIUM, THUS IT WAS PULLED BACK INTO RIGHT ATRIUM. ONCE IT WAS DETERMINED THE VERSACROSS WIRE WAS NOT VISIBLE IN THE LEFT ATRIUM, THE VERSACROSS SHEATH WAS NOT ADVANCED INTO THE LEFT ATRIUM (IT STAYED ON THE RIGHT SIDE). THEN, THE LOCATION OF THE VERSACROSS RF WIRE AND THE PATIENT CONDITION/STABILITY WERE REASSESSED. ALL PATIENTS VITALS WERE STABLE. ABOUT 15 MINUTES AFTER THE TRANSSEPTAL PUNCTURE, THERE WAS A THOUGHT OF POTENTIAL HEMATOMA AND A RESULTING DROP IN BLOOD PRESSURE. THIS TURNED OUT TO BE FALSE AND THE DROP OF BLOOD PRESSURE WAS MOST LIKELY DUE TO PROTAMINE INFUSION. N

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 18074253 ↗
• MalfunctionOct 23, 2023Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS STEERABLE ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION. DURING TRANSSEPTAL, THE VERSARCROSS RF WIRE DID NOT DELIVER RADIO FREQUENCY. THE RADIO FREQUENCY WAS NOT SEEN APPLIED VIA INTRACARDIAC ULTRASOUND (ICE) IMAGING. NO DAMAGE TO THE BMC RF GENERATOR WAS REPORTED. ACCORDING TO THE PHYSICIAN, RADIO FREQUENCY WAS NOT DELIVERED. A NORMAL BEEP WHEN RADIO FREQUENCY IS DELIVERED WAS HEARD. ALL CONNECTIONS WERE CHECKED PRIOR TO TRANSSEPTAL. EVERYTHING WAS DOUBLE CHECKED AND CONFIRMED CORRECT SET UP. THE WIRE WAS TENTING THE SEPTAL TISSUE 2-3 MM OUT OF THE DILATOR. IT WAS REPORTED THAT THE CONNECTOR CABLE WAS FAULTY/DAMAGED. HENCE, TO COMPLETE THE PROCEDURE, A NEW VERSACROSS KIT WAS OPENED TO USE A NEW CABLE AND SUCCESSFULLY PERFORMED TRANSSEPTAL. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CONNECTOR CABLE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NOTHING RELATED TO THE ANATOMY OF THE PATIENT WAS NOTED THAT COULD LEAD TO THIS COMPLAINT. NO OTHER ISSUES WERE REPORTED. IT WAS FURTHER CONFIRMED (25OCT2023) THAT THERE WAS NO ERROR CODE / SOUND GIVEN. THE RADIO FREQUENCY SIMPLY NEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985307 ↗
• MalfunctionMar 31, 2023Leak/Splash; Defective Device; Leak/Splash; Defective Device

  IT WAS REPORTED THAT THE SHEATH EXHIBITED A SHEATH LEAK AND A TEAR IN THE HEMOSTATIC VALVE. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) A VERSACROSS STEERABLE ACCESS SOLUTION SHEATH WAS SELECTED FOR USE. THE SHEATH EXHIBITED A HEMOSTATIC VALVE LEAK. THE LEAK WAS A SLOW DRIP OF SALINE WITH NOT A LOT OF BLOOD PRESENT. BACKLOADING THE DILATOR INTO THE SHEATH MAY HAVE TORN THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED WITH ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655439 ↗