ULTIMUM™ 407687Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734020930), received between Aug 18, 2020 and Feb 26, 2026 — classified as 7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fluid/Blood Leak

  DURING A TAVI PROCEDURE, WHILE ACCESSING THE FEMORAL ARTERY USING THE INTRODUCER AND A NON-ABBOTT GUIDEWIRE (LUNDERQUIST BY COOK MEDICAL), BLOOD LEAKED FROM THE HEMOSTASIS VALVE RESULTING IN SIGNIFICANT BLOOD LOSS. MANUAL COMPRESSION WITH GAUZE WAS HELD AT THE VALVE OF THE INTRODUCER. THE BLEEDING RESULTED IN A MARKED DECREASE IN THE PATIENT¿S HEMOGLOBIN LEVELS: ON (B)(6) 2026 HB: 13.8; ON (B)(6) 2026 HB: 11.9. NO INTERVENTION WAS ADMINISTERED TO TREAT THE DROP IN HEMOGLOBIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24457559 ↗
• MalfunctionOct 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTATIC VALVE STARTED LEAKING ONCE THE WIRE WAS INSERTED. A 14F NON-ABBOTT SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10623506 ↗
• MalfunctionOct 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTATIC VALVE OF THE SHEATH STARTED LEAKING AFTER TAKING OUT THE BALLOON FOR THE PRE-DILATION. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT 14F SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10623452 ↗
• MalfunctionSep 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, THE HEMOSTATIC VALVE STARTED LEAKING AFTER TAKING OUT THE BALLOON FOR THE PRE-DILATATION. THE PROCEDURE WAS COMPLETED WITH THE SAME SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494638 ↗
• MalfunctionSep 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTATIC VALVE STARTED LEAKING AFTER THE BALLOON WAS TAKEN OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH BY INSERTING A 6F SHEATH INSIDE THE 14F SHEATH TO STOP THE LEAK WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494635 ↗
• MalfunctionSep 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTATIC VALVE STARTED LEAKING AFTER TAKING OUT THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THE SAME SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494629 ↗
• MalfunctionAug 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, AFTER REMOVING THE BALLOON, THE VALVE OF THE SHEATH STARTED LEAKING. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423624 ↗