VersaCross Access Solution VXSK0031 (UDI 00685447017349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00685447017349), received between Sep 27, 2022 and Mar 31, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN OR PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE VERSACROSS RF WIRE WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE VERSACROSS DILATOR. A SECOND KIT WAS OPENED, AND SAME ISSUE WAS EXPERIENCED. BOTH WIRES WOULD NOT COME OUT OF THE TIP OF THE DILATOR. THUS, A THIRD KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (RETAINED BY CUSTOMER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732858 ↗
• MalfunctionMar 31, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN OR PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE VERSACROSS RF WIRE WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE VERSACROSS DILATOR. A SECOND KIT WAS OPENED, AND SAME ISSUE WAS EXPERIENCED. BOTH WIRES WOULD NOT COME OUT OF THE TIP OF THE DILATOR. THUS, A THIRD KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (RETAINED BY CUSTOMER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732500 ↗
• MalfunctionMar 26, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE INDICATED FOR A PAROXYSMAL ATRIAL FIBRILLATION CASE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. WHEN THE PHYSICIAN ATTEMPTED TO PERFORM TRANSSEPTAL PUNCTURE, THE RADIO FREQUENCY (RF) WIRE WAS UNSUCCESSFUL CROSSING THE SEPTUM. THERE WERE SEVEN RF ATTEMPTS TAKEN INCLUDING REPOSITIONING THE DILATOR HOWEVER THE WIRE WOULD NOT CROSS. THUS, A VERSACROSS CONNECT KIT WAS OPENED AND TRANSSEPTAL WAS ACHIEVED IN FIRST ATTEMPT. NO PATIENT COMPLICATIONS OCCURRED. 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 21701081 ↗
• MalfunctionJan 8, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE DURING AN ABLATION PROCEDURE. THE PHYSICIAN REPORTED THAT THE STARTER WIRE FRAYED WITHIN VERSACROSS SHEATH DURING PREP. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THE PRODUCT IS NOT AVAILABLE TO RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106965 ↗
• MalfunctionSep 27, 2022Defective Device; Output Problem

  HANDED OFF A VERSACROSS CATHETER FOR TRANS SEPTAL PUNCTURE AND THE GENERATOR DIDN'T RECOGNIZE THE CATHETER INDICATING A DEFECTIVE WIRE.

  Patient problems: Insufficient Information

  MAUDE report 15492293 ↗