ULTIMUM™ 407843Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734011051), received between Aug 3, 2018 and Jun 13, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REF: 3005334138-2023-00268. DURING AN ADRENAL ARTERY EMBOLIZATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTATIC VALVE OF 2 DEVICES. A THIRD INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119433 ↗
• MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REF: 3005334138-2023-00269. DURING AN ADRENAL ARTERY EMBOLIZATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTATIC VALVE OF 2 DEVICES. A THIRD INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119408 ↗
• MalfunctionJun 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING A TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE VIA FEMORAL ACCESS, A BLOOD LEAK WAS NOTED FROM THE HEMOSTATIC VALVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058575 ↗
• MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A BLOOD LEAK OCCURRED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER WHEN CATHETER WAS REMOVED. AN ANGIOSEAL DEVICE WAS THEN USED TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066062 ↗
• MalfunctionMar 3, 2022Difficult to Insert; Difficult to Insert

  DURING AN EXPLORATORY PROCEDURE BY CATHETERIZATION OF THE ADRENAL VEINS FOR PRIMARY HYPERALDOSTERONISM FOR A PATIENT WITH A HISTORY OF ARTERIAL HYPERTENSION, INITIALLY BOTH THE NON-ABBOTT CATHETER AND CATHETER GUIDE WERE ABLE TO BE INSERTED THROUGH THE INTRODUCER. UPON RE-ENTRANCE, THE CATHETER AND THE CATHETER GUIDE WERE NOT ABLE TO BE FULLY INSERTED INTO THE INTRODUCER. EVENTUALLY THE CATHETER WAS ABLE TO PASS THROUGH THE INTRODUCER PARTIALLY, WHICH ALLOWED MANIPULATION OF THE CATHETER. BECAUSE OF THE ISSUE, A PROLONGATION OF THE INTERVENTION AND ADDITIONAL STRESS ON THE PATIENT OCCURRED DUE TO THE PATIENT BEING UNDER LOCAL ANESTHESIA FOR THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663452 ↗
• MalfunctionJun 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE SHEATH WAS PLACED WITHOUT THE GUIDEWIRE AND A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10158299 ↗
• MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AFTER THE PUNCTURE WAS PERFORMED, THE CATHETER WAS PLACED INSIDE THE SHEATH, AND THE VALVE WAS LEAKING BLOOD. ANOTHER SHEATH WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224553 ↗
• MalfunctionAug 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE VALVE ON THE ULTIMUM HEMOSTASIS INTRODUCER WAS DEFECTIVE AND THE DEVICE LEAKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7746748 ↗