ULTIMUM™ 407847Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734008969), received between Oct 2, 2018 and Feb 18, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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.

• MalfunctionFeb 18, 2026Fluid/Blood Leak

  DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, BLOOD LEAKED FROM THE SHEATH. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382291 ↗
• InjuryAug 10, 2023Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN REMOVING THE SHEATH SHEERED 1 CM DISTAL FROM THE HUB. ULTRASOUND WAS USED TO IDENTIFY THE RIGHT FEMORAL VEIN, PROXIMAL TO THE BIFURCATION. A SELDINGER NEEDLE WAS INTRODUCED INTO THE VESSEL AND THE VESSEL WAS ASPIRATED, AFTER ASPIRATION A GUIDE WIRE WAS INTRODUCED INTO THE NEEDLE. AFTER GUIDE WIRE PLACEMENT, AN 11 BLADE WAS USED TO LANCE THE SKIN AT THE JUNCTION OF THE WIRE WITH THE BLADE FACING LATERALLY. A 7 FR AND 8.5 FR SHORT SHEATH WERE THEN PASSED OVER THE WIRE INTO THE VESSEL. BOTH PASSED SMOOTHLY AND WITHOUT RESISTANCE. THE DILATOR AND WIRE WERE THEN REMOVED FROM THE SHEATH HUB, WITH A LEFT HAND PLACED ON THE HUB TO STABILIZE WHILE THE RIGHT HAND APPLIED LIGHT DOWNWARD PRESSURE TO DISCONNECT THE SHEATH FROM THE HUB. AT THE CONCLUSION OF THE CASE, THE SHORT SHEATHS WERE PULLED WITH GENTLE TRACTION DISTALLY. THE 7 FR SHEATH SHEERED 1 CM DISTAL FROM THE HUB. THIS PORTION OF SHEATH WOULD HAVE BEEN WITHIN THE SOFT TISSUE DURING THE CASE. AN INTERVENTIONAL RADIOLOGIST REMOVED THE REMAINDER OF THE SHEATH FROM PATIENT WHICH ADDED 2.5 HOURS TO THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17499493 ↗
• InjuryApr 5, 2021Difficult to Insert; Expiration Date Error; Difficult to Insert; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THE EVENT DATE IS UNKNOWN, THEREFORE AN EVENT OF AN EXPIRED DID NOT OCCUR AND SHOULD NOT HAVE BEEN SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613684 ↗
• MalfunctionDec 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  MANUFACTURING RELATED REF: 3005334138-2018-00485, 3005334138-2018-00483. DURING A PROCEDURE BLOOD WAS NOTED LEAKING FROM THE HEMOSTASIS VALVE. THE PHYSICIAN ATTEMPTED WITH TWO ADDITIONAL INTRODUCERS AND A LEAK WAS OBSERVED. A NON-ABBOTT DEVICE WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160728 ↗
• MalfunctionDec 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  MANUFACTURING RELATED REF: 3005334138-2018-00483, 3005334138-2018-00486. DURING A PROCEDURE BLOOD WAS NOTED LEAKING FROM THE HEMOSTASIS VALVE. THE PHYSICIAN ATTEMPTED WITH TWO ADDITIONAL INTRODUCERS AND A LEAK WAS OBSERVED. A NON-ABBOTT DEVICE WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160723 ↗
• MalfunctionDec 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  MANUFACTURING RELATED REF: 3005334138-2018-00485, 3005334138-2018-00486. DURING A PROCEDURE BLOOD WAS NOTED LEAKING FORM THE HEMOSTASIS VALVE. THE PHYSICIAN ATTEMPTED WITH TWO ADDITIONAL INTRODUCERS AND A LEAK WAS OBSERVED. A NON-ABBOTT DEVICE WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160718 ↗
• InjuryOct 19, 2018Failure to Auto Stop; Failure to Auto Stop

  WHEN THE DILATOR WAS WITHDRAWN FROM THE SHEATH WHILE INSIDE THE PATIENT, ARTERIAL BLOOD HEMORRHAGED OUT. THERE WAS NO STOP MECHANISM AS EXPECTED ON THE DEVICE. AS TREATMENT, THE SHEATH WAS REMOVED AND MANUAL PRESSURE WAS HELD. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7985296 ↗
• MalfunctionOct 8, 2018Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE ULTIMUM HEMOSTASIS INTRODUCER EXPERIENCED BACK FLOW OF BLOOD AND LEAKED EXCESSIVELY FROM THE VALVE ONTO THE STERILE DRAPE. THE SAME ULTIMUM HEMOSTASIS INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943944 ↗
• MalfunctionOct 2, 2018Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  THE ULTIMUM HEMOSTASIS INTRODUCER EXPERIENCED BACK FLOW OF BLOOD AND LEAKED EXCESSIVELY FROM THE VALVE ONTO THE STERILE DRAPE. ALLEGEDLY THIS OCCURRED MULTIPLE TIMES OVER THE PAST FEW WEEKS. ANOTHER ULTIMUM HEMOSTASIS INTRODUCER OF A DIFFERENT BATCH WAS USED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928152 ↗