VersaCross Access Solution VXSK0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447011767), received between Jun 12, 2024 and Jun 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  AN AIR EMBOLISM OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A VERSACROSS ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. IT WAS REPORTED THAT THE MONITOR DISPLAYED "AIR INGRESS", THUS THE PROCEDURE WAS CANCELLED. THE PHYSICIAN ASPIRATED THE EMBOLISM AND CONFIRMED THAT THERE WAS AIR INSIDE OF THE PATIENT ON IMAGING. NO OTHER ISSUES WERE REPORTED. A NON-BOSTON SCIENTIFIC SMALL BORE LASSO CATHETER WAS USED AFTER TRANSSEPTAL. THE IRRIGATION WAS NEVER INTERRUPTED OR STOPPED DURING THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE VERSACROSS DEVICES DID NOT MALFUNCTION DURING THE PROCEDURE NOR CONTRIBUTE TO THE ADVERSE EVENT. IT IS EXPECTED FOR THE PATIENT TO FULLY RECOVER. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT WAS FURTHER REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS ALSO SELECTED FOR USE FOR THE WATCHMAN PROCEDURE, GUIDED BY A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE VERSACROSS RF WIRE WAS USED AS A STARTER WIRE. A TOTAL OF FOUR (4) TRANSSEPTAL PUNCTURES ATTEMPTS (TSP) WITH VERSACROSS CONNECT WERE DONE, ALL TOO POSTERIOR AND HIGH, LEADING TO MULTIPLE FAILED WATCHMAN DEPLOYMENTS. THEREFOR

  Patient problems: Air Embolism; Ischemia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 19523240 ↗