Export Advance™Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169647343), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE AN EXPORT ADVANCE ASPIRATION CATHETER. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU. THE DEVICE WAS INSPECTED AND PREPPED PER IFU. NO DIFFICULTIES WERE ENCOUNTERED WHILE INSERTING THE DEVICE. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT WHEN THE DEVICE WAS INSIDE THE PATIENT IT WAS NOTED THAT THE RADIOPAQUE MARKER WAS MISSING FROM DEVICE. NO INTERVENTION WAS REQUIRED TO REMOVE THE RADIOPAQUE MARKER. THE DEVICE WAS REMOVED FROM THE PATIENT WHEN IT WAS DETERMINED THAT THERE WAS NO MARKERBAND. NO DAMAGE WAS NOTED TO THE TIP OF THE DEVICE AFTER REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974246 ↗