ULTIMUM™ 407832Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734008822), received between Feb 15, 2019 and Mar 21, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE RIGHT LEG PERIPHERAL ARTERIAL OCCLUSION DISEASE, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PAOD PTA) SURGERY, A FLUID LEAK OCCURRED. THE SHEATH WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL ARTERY. WHILE FLUSHING WITH NORMAL SALINE, IT WAS OBSERVED THAT THE HEMOSTASIS VALVE OF THE SHEATH WAS LEAKING. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950496 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A VASCULAR ANGIOPLASTY PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646596 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REF: 3005334138-2023-00122. DURING THE PERCUTANEOUS TRANSLUMINAL AORTIC VALVULOPLASTY (PTAV) PROCEDURE, BLOOD LEAKS OCCURRED WITH THE VALVE ON TWO SHEATHS. AFTER PUNCTURE IN THE ANTEBRACHIAL VEIN, THE PHYSICIAN FOUND THE VALVE WAS LEAKING BLOOD. THE SHEATH WAS THEN REPLACED, BUT THE SECOND SHEATH HAD THE SAME ISSUE. THE PHYSICIAN THOUGHT THE SITUATION WAS BETTER THAN WITH THE FIRST SHEATH AND SO IT WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624590 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REF: 3005334138-2023-00123. DURING THE PERCUTANEOUS TRANSLUMINAL AORTIC VALVULOPLASTY (PTAV) PROCEDURE, BLOOD LEAKS OCCURRED WITH THE VALVE ON TWO SHEATHS. AFTER PUNCTURE IN THE ANTEBRACHIAL VEIN, THE PHYSICIAN FOUND THE VALVE WAS LEAKING BLOOD. THE SHEATH WAS THEN REPLACED, BUT THE SECOND SHEATH HAD THE SAME ISSUE. THE PHYSICIAN THOUGHT THE SITUATION WAS BETTER THAN WITH THE FIRST SHEATH AND SO IT WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624587 ↗
• MalfunctionMar 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE PHYSICIAN INSERTED THE SHEATH INTO THE FEMORAL VEIN, AND A BLOOD LEAK WAS NOTED AT THE VALVE. THE PHYSICIAN REPLACED THE SHEATH TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551005 ↗
• MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) PROCEDURE, THE INTRODUCER VALVE HAD A BLOOD LEAK. PROCEDURE WAS COMPLETED WITHOUT EXCHANGING THE INTRODUCER AND THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848573 ↗
• MalfunctionNov 4, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THERE WAS AN AIR LEAK FROM THE INTRODUCER. THE DOCTOR USED A SYRINGE TO ASPIRATE BUT FOUND AIR DRAWN FROM THE TUBE AFTER LIMITED BLOOD RETURN. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736329 ↗
• MalfunctionOct 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SURGERY, A BLOOK LEAK WAS NOTED AT THE VALVE (REGARDLESS OF USE OF A GUIDEWIRE). ANOTHER SHEATH WAS GOING TO BE USED, HOWEVER, THE PATIENT'S VESSEL WAS NOT AVAILABLE TO INSERT A DEVICE AGAIN, SO HE DECIDED TO CONTINUE THE SURGERY WHILE THE PATIENT WAS STILL BLEEDING. THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658122 ↗
• MalfunctionFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, THE HUB OF THE ULTIMUM HEMOSTASIS INTRODUCER CAME APART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8346300 ↗