ULTIMUM™ 407849Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734011099), received between Jul 28, 2021 and Aug 23, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A RIGHT-SIDED PROCEDURE, THERE WAS A BLOOD CLOT NOTED IN THE SHEATH. THE SHEATH AND DILATOR WERE PREPPED, AND THE SIDE PORT WAS FLUSHED. THE SHEATH AND CATHETER WERE PLACED IN THE FEMORAL VEIN, BUT THE SHEATH WAS NOT CONSTANTLY IRRIGATED WITH HEPARINIZED SALINE AS ROUTINE PRACTICE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17607867 ↗
• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AFTER THE PROCEDURE, WHILE THE PATIENT WAS IN THE INPATIENT SETTING IN THE CCU, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS CAP OF THE INDWELLING INTRODUCER UPON FLUSHING. THE INTRODUCER WAS REMOVED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166823 ↗
• MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, WHILE FLUSHING FLUID WAS NOTED FROM THE HEMOSTASIS CAP UP INTO THE STERILE SLEEVE. THE SHEATH WAS REMOVED TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT WAS IN THE CCU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126102 ↗
• InjurySep 8, 2021Material Separation; Material Separation

  DURING THE PROCEDURE, PART OF THE SHEATH DETACHED WHILE ACCESSING THE PATIENT'S FEMORAL VEIN. THE PIECE OF THE SHEATH WAS SUCCESSFULLY REMOVED USING A SNARE. THE PROCEDURE WAS STILL ABLE TO BE COMPLETED DESPITE THE ISSUE.

  Patient problems: Foreign Body Embolism

  MAUDE report 12439707 ↗
• InjuryJul 28, 2021Break

  WHEN ACCESSING VEINS IN GROIN, 8 FR SHEATH BROKE OFF IN PATIENT'S RIGHT FEMORAL VEIN. VASCULAR SURGEON CAME IN TO SNARE AND REMOVE BROKEN SHEATH SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12238109 ↗