ULTIMUM™ 407845Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05414734011075), received between Sep 18, 2018 and Apr 2, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751442 ↗
• InjuryJun 10, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING PAROXYSMAL PROCEDURE, THE STYLET BROKE THE PURGE LINE WHICH RESULTED IN PATIENT BLEEDING. THE DEVICE WAS EXCHANGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19504734 ↗
• MalfunctionMar 11, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IT WAS NOTED THAT THERE WAS A HOLE IN THE SHEATH. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AT THE END OF THE PROCEDURE, EXOSEAL WAS ABOUT TO BE PERFORMED WHEN THE CLOSURE DEVICE WOULD NOT ADVANCE. THE SHEATH WAS EXCHANGED AND UPON REMOVAL A HOLE WAS OBSERVED. IT IS UNKNOWN IF THIS OCCURRED WHEN THE EXOSEAL WAS BEING INTRODUCED OR AT SOME OTHER POINT. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT INTRODUCER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT IS NOTED THAT THE AFFECTED SHEATH INSERTED WITHOUT ISSUE AND THE RIGHT COMMON FEMORAL ARTERY ANGIOGRAM LOOKED GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874162 ↗
• MalfunctionAug 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A RIDE-SIDED PROCEDURE, THERE WAS A BLOOD CLOT NOTED IN THE SHEATH. THE SHEATH AND DILATOR WERE PREPPED, AND THE SIDE PORT WAS FLUSHED. THE SHEATH AND CATHETER WERE PLACED IN THE FEMORAL VEIN, BUT THE SHEATH WAS NOT CONSTANTLY IRRIGATED WITH HEPARINIZED SALINE AS ROUTINE PRACTICE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17607971 ↗
• InjuryJun 5, 2023Material Separation; Material Separation

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A PORTION OF THE SHEATH REMAINED IN THE PATIENT AND AN EFFUSION WAS NOTED. AT THE END OF THE PROCEDURE, WHEN THE SHEATHS WERE BEING REMOVED, A PORTION OF ONE SHEATH REMAINED IN THE PATIENT'S RIGHT EXTERNAL ILIAC VEIN. THE PATIENT ALSO EXPERIENCED A PERICARDIAL EFFUSION. AN X-RAY IMAGE WAS TAKEN TO CONFIRM WHERE THE RETAINED SHEATH WAS, HOWEVER ATTEMPTS TO RETRIEVE IT WERE UNSUCCESSFUL AND MANUAL COMPRESSION WAS ADMINISTERED.

  Patient problems: Cardiac Perforation; Foreign Body In Patient

  MAUDE report 17067088 ↗
• MalfunctionFeb 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REF: 3005334138-2023-00035. DURING THE LEFT HEART CATHETER PROCEDURE, THERE WAS A CONSTANT TRICKLE OF BLOOD OUT OF THE HEMOSTATIC VALVE. IT WAS ATTEMPTED TO REINSERT THE INNER STYLET TO SEE IF IT WOULD RESEAL WITHOUT SUCCESS. THE INTRODUCER WAS REPLACED, BUT THE BLEEDING WAS NOT SIGNIFICANT ENOUGH TO REQUIRE ANOTHER REPLACEMENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302103 ↗
• MalfunctionFeb 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REF: 3005334138-2023-00036. DURING THE LEFT HEART CATHETER PROCEDURE, THERE WAS A CONSTANT TRICKLE OF BLOOD OUT OF THE HEMOSTATIC VALVE. IT WAS ATTEMPTED TO REINSERT THE INNER STYLET TO SEE IF IT WOULD RESEAL WITHOUT SUCCESS. THE INTRODUCER WAS REPLACED, BUT THE BLEEDING WAS NOT SIGNIFICANT ENOUGH TO REQUIRE ANOTHER REPLACEMENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302102 ↗
• MalfunctionOct 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AFTER A DIAGNOSTIC PROCEDURE, THERE WAS BLEEDING FROM THE GREEN VALVE ON THE INTRODUCER. IT WAS NOT THOUGHT THAT THE VALVE WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITHOUT DEVICE REPLACEMENT AND WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541396 ↗
• MalfunctionApr 13, 2022Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SIDE PORT/STOPCOCK DETACHED FROM THE SHEATH. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102951 ↗
• MalfunctionJun 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING A CORONARY ANGIOGRAPHY FOR NSTEMI, A LEAKAGE AND REFLUX OF BLOOD OCCURRED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184812 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00425, 3005334138-2019-00426. FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE. FOLLOWING THE PROCEDURE, THE PATIENT WAS OBSERVED IN THE HOSPITAL FOR 8 DAYS AND THEN DISCHARGED. A FEW DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL FOR A STROKE. THE PATIENT WAS ALERT ON (B)(6) 2019. PARALYSIS OF ONE SIDE OF THE BODY SEEMED TO BE REGRESSING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Stroke/CVA

  MAUDE report 8854749 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00425, 3005334138-2019-00427 FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE. FOLLOWING THE PROCEDURE, THE PATIENT WAS OBSERVED IN THE HOSPITAL FOR 8 DAYS AND THEN DISCHARGED. A FEW DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL FOR A STROKE. THE PATIENT WAS ALERT ON (B)(6) 2019. PARALYSIS OF ONE SIDE OF THE BODY SEEMED TO BE REGRESSING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Stroke/CVA

  MAUDE report 8854745 ↗
• MalfunctionApr 4, 2019Dull, Blunt; Positioning Problem

  A ST JUDE ULTIMUM 6F SHEATH WAS OPENED FOR PLACEMENT IN THE PATIENT'S FEMORAL ARTERY; THE PATIENT WAS UNDERGOING CARDIAC CATHETERIZATION. THE INTRODUCER, INCLUDED IN THE PACKAGING WITH THE SHEATH, COULD NOT BE INTRODUCED INTO THE SHEATH (THROUGH THE PROXIMAL DIAPHRAGM AT THE HUB). UPON FURTHER INSPECTION, IT WAS NOTED THE DISTAL END WAS NOT TAPERED AS INTENDED BUT INSTEAD BLUNT. THE SHEATH WAS REMOVED FROM THE FIELD AND ANOTHER SHEATH WAS OPENED AND UTILIZED. THE INVENTORY, WITHIN THE CATH LAB, WAS INSPECTED AND ALL OTHER SHEATHS WITH THE LOT NUMBER OF THIS DEVICE APPEARED TO BE TAPERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8481969 ↗
• InjurySep 18, 2018Material Twisted/Bent; Material Twisted/Bent

  DURING INSERTION TO THE FEMORAL ARTERY, THE ULTIMUM HEMOSTASIS INTRODUCER BECAME KINKED. DUE TO THE KINK, THE WIRE WAS LOST IN THE ARTERY. BEFORE A NEW ATTEMPT, THE ARTERY HAD TO BE COMPRESSED AND THERE WAS A 15 MINUTE DELAY. AFTER COMPRESSION, A NEW PUNCTURE WAS MADE. IN ORDER TO AVOID ANOTHER KINK, 3 OTHER INTRODUCERS WERE USED TO DILATE THE ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887325 ↗