VersaCross™ Access Solution VXSK0121Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00685447019817), received between Oct 23, 2025 and Sep 29, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a left atrial appendage (LAA) procedure under general anesthesia, a VersaCross Access Solution was used for transseptal access. Baseline imaging with TEE identified a pre-existing pericardial effusion measuring 0.7 cm, with fluid noted behind the LAA and around the RV. A non-Boston Scientific mapping Catheter was used intra-procedurally. The physician performed a transseptal puncture using an 8.5F fixed VersaCross sheath and VersaCross pigtail wire. After the wire was advanced into the LAA and the sheath withdrawn, a non-Boston Scientific sheath was loaded over the wire. At that time, the ICE representative noted a growing pericardial effusion, which was subsequently confirmed by TEE. The patient became hemodynamically unstable with a drop in blood pressure, prompting emergent pericardiocentesis. Approximately 1,500 mL of bright red blood was evacuated and returned to the patient via cell saver autotransfusion. Due to continued blood re-accumulation, the patient was transferred to surgery, where an LAA perforation attributed to the VersaCross wire was reportedly confirmed and managed with a pericardial window and LAA clipping. On the following day, the p

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

  MAUDE report 50933346 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50240115 ↗
• MalfunctionJul 20, 2026Off-Label Use; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883956 ↗
• MalfunctionMar 20, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE COATING CAME OFF IN THE MIDDLE OF VERSACROSS WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT DEVICE (SAME MODEL, BOSTON SCIENTIFIC PRODUCT). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED, THE DAMAGE WAS OBSERVED AFTER THE WIRE AND DILATOR WERE REMOVED. THE WIRE WAS PULLED BACK INTO THE SHEATH/ DILATOR ONCE THE SHEATH WAS IN THE SUPERIOR VENA CAVA (SVC). THE WIRE WAS THEN PULLED BACK AGAIN WHEN REMOVED. THE DILATOR WAS ALREADY BACKLOADED ONTO THE WIRE/INSIDE THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650221 ↗
• InjuryNov 13, 2025Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS ACCESS SOLUTION SELECTED FOR USE. DURING PREPARATION, RF WIRE WAS NOTED TO BE FRAYED WHEN OPENED THE PACKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING DIFFERENT DEVICE, SAME MODEL. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544914 ↗
• MalfunctionOct 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING FARAPULSE PROCEDURE, A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BACK OF RF WIRE WAS PEELING OFF. THUS, THE PHYSICIAN OPTED TO OPEN A REPLACEMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373148 ↗