VersaCross™ Steerable Access Solution VSTK0121Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447019701), received between May 5, 2025 and Apr 3, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Nonstandard Device; Material Perforation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A FARAWAVE PULMONARY VEIN ISOLATION AND POSTERIOR WALL ISOLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, A TORFLEX SHEATH WAS SELECTED FOR USE. FOLLOWING TRANSSEPTAL PUNCTURE WITH THE RF WIRE, THE PHYSICIAN MET SIGNIFICANT RESISTANCE ATTEMPTING TO CROSS THE SEPTUM WITH THE SHEATH AND WAS UNABLE TO SUCCESSFULLY CROSS WITH SHEATH AND DILATOR. A NEW TRANSEPTAL PUNCTURE WAS ATTEMPTED AT THREE SEPARATE LOCATIONS, BUT IT CONTINUED TO BE UNSUCCESSFUL WHEN ATTEMPTING TO CROSS. IT WAS ATTEMPTED TO DILATE TRANSEPTAL LOCATION WITH NON-BOSTON SCIENTIFIC (BSC) CATHETER, BUT IT WAS STILL UNSUCCESSFUL. TORFLEX SHEATH AND DILATOR WAS EXCHANGED FOR NON-BSC SHEATH, AND UPON EXAMINING THE TORFLEX SHEATH, THE PHYSICIAN NOTICED THE TIP OF THE SHEATH WAS SPLIT AND BROKEN. THE SEPTUM WAS SUCCESSFULLY CROSSED WITH THE NON-BSC SHEATH SHEATH AND DILATOR. THE NON-BSC SHEATH WAS THEN EXCHANGED FOR A FARADRIVE SHEATH AND PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778774 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS ABORTED. A CONCOMITANT PROCEDURE WHERE A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE AND A PULSE FIELD ABLATION (PFA) WERE BEING PERFORMED, A VERSACROSS STEERABLE ACCESS SOLUTION KIT WAS SELECTED FOR USE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING WAS UTILIZED. A PRE-PROCEDURE EFFUSION WAS NOTED ON IMAGING BUT LOCATION AND SIZE ARE UNKNOWN. HEPARIN WAS GIVEN FOR ANTICOAGULATION INTRAPROCEDURE. THE TRANSSEPTAL PUNCTURE (TSP) WAS COMPLETED. THE PFA WAS PERFORMED USING FARAPULSE PFA SYSTEM. SUBSEQUENTLY THE LAA CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS) WAS INSERTED AND POSITIONED AT THE LAA. A 27MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS ADVANCED AND DEPLOYED, YET THE PHYSICIAN WAS NOT CONFIDENT IN POSITIONING OF THE DEVICE, SO IT WAS RECAPTURED AND REMOVED. HYPOTENSION WAS NOTED WHILE THE PHYSICIAN EXCHANGED THE WAS FOR A WATCHMAN FXD SINGLE CURVE ACCESS SYSTEM. THE PE WAS ANALYZED, AND IT DID NOT GROW IN SIZE. PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN, AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH NOTED THE PE DID NOT GROW IN SIZE

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 21961472 ↗