ULTIMUM™ 407844Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734008921), received between Mar 3, 2020 and Mar 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMar 1, 2021Fracture; Fracture

  DURING THE PROCEDURE, THE INTRODUCER CRACKED WHILE BEING INTRODUCED INTO THE PATIENT. THE DEVICE WAS REPLACED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392197 ↗
• MalfunctionMar 3, 2020Difficult to Insert; Difficult to Remove; Material Twisted/Bent; Difficult to Insert; Difficult to Remove; Material Twisted/Bent

  DURING THE PROCEDURE, THE SHEATH WAS DIFFICULT TO ADVANCE AND BECAME TWISTED INSIDE OF THE PATIENT. THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT, BUT WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9779899 ↗