ULTIMUM™ C407698Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067009692), received between Jul 16, 2018 and Sep 11, 2020 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE TAVI PROCEDURE, IT WAS NOTICED THAT THE PATIENT DID NOT HAVE ANY PULSATION IN THE LEFT LEG. A CONTRAST INJECTION OF THE LEFT FEMORAL CONFIRMED AN OBSTRUCTION AROUND THE FEMORAL HEAD. AN ENDARTERECTOMY WAS PERFORMED WHICH WENT WELL. THE PATIENT IS DOING FINE NOW AND IS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 10520484 ↗
• MalfunctionJul 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, THE VALVE OF THE SHEATH STARTED LEAKING. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830507 ↗
• MalfunctionMay 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE SHEATH WAS LEAKING FROM THE HEMOSTASIS VALVE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642091 ↗
• InjuryJul 16, 2018Material Separation; Material Separation

  AFTER A PORTICO PROCEDURE, THE ULTIMUM HEMOSTASIS INTRODUCER WAS REMOVED BUT THE HEMOSTASIS VALVE DETACHED FROM THE SHAFT, WHICH CAUSED A MASSIVE HEMORRHAGE. WHILE THE SHAFT WAS STILL INSIDE THE LEFT ILIAC ARTERY, MANUAL COMPRESSION WAS APPLIED TO THE GROIN TO MAINTAIN FEMORAL HEMOSTASIS, BUT THE COMPRESSION DEFORMED THE SHAFT OF THE INTRODUCER. THE DEFORMED SHAFT THEN CAUSED AN ILIAC LESION, WHICH WAS TREATED WITH A FOUR COVERED STENT. THE LEFT ILIAC ARTERY WAS STILL PERVIOUS MULTIPLE DAYS AFTER THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7690164 ↗