Ultimum™ C407699Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05415067014382), received between Jun 29, 2018 and Mar 19, 2020 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE VALVE WAS LEAKING. WHEN THE WIRE WAS INSERTED, THE VALVE BEGAN TO LEAK. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856313 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PORTICO PROCEDURE WITH PERFECT VALVE POSITIONING AND GOOD RESULTS, AN EFFUSION OCCURRED. AFTER THE SHEATH REMOVAL, A CONTROL ANGIO SHOWED A LEFT COMMON FEMORAL ARTERY EFFUSION. A COVERED STENT WAS DEPLOYED FROM THE CONTROLATERAL CFA BUT AFTER MID RELEASE THE DEPLOYMENT SYSTEM HAS BLOCKED AND WAS IMPOSSIBLE THE COMPLETE STENT DEPLOYMENT. THE COVERED STENT WAS REMOVED PARTIALLY OPEN FROM THE RIGHT CFA. THIS MANEUVER CAUSED A VASCULAR LESION THAT INVOLVED BOTH THE RIGHT SUPERFICIAL AND THE DEEP FEMORAL ARTERIES. THE PATIENT EXPERIENCES HYPOTENSION AND WAS TREATED WITH LIQUIDS AND A BLOOD INFUSION. ALL 3 VASCULAR INJURIES WERE TREATED WITH COVER STENTS AND A COMPLETE HEMOSTASIS WAS OBTAINED. THE PATIENT CONTINUED THE NORMAL POST-OPERATIVE COURSE. IT IS UNKNOWN IF THE EFFUSION WAS CAUSED BY THE INTRODUCER.

  Patient problems: Perforation of Vessels

  MAUDE report 9602402 ↗
• MalfunctionJan 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE SHEATH STARTED LEAKING THROUGH THE VALVE. THE SAME SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578072 ↗
• MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE VALVE OF THE SHEATH WAS LEAKING. THE PATIENT'S BLOOD PRESSURE DROPPED SLIGHTLY. CONSTANT PRESSURE WAS REQUIRED AROUND THE SHEATH VALVE TO MINIMIZE THE BLEEDING. AFTER VALVE DEPLOYMENT, THE SHEATH WAS REMOVED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511526 ↗
• MalfunctionAug 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE VALVE OF THE SHEATH WAS LEAKING. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914928 ↗
• MalfunctionAug 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE VALVE OF THE SHEATH WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH THE SAME SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870895 ↗
• MalfunctionAug 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE VALVE OF THE INTRODUCER WAS LEAKING. ANOTHER INTRODUCER WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870327 ↗
• MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THERE WAS BLOOD LEAKING FROM THE VALVE OF THE INTRODUCER. PRIOR TO THE LEAK, A SHAPED GUIDEWIRE HAD BEEN INSERTED INTO THE INTRODUCER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795109 ↗
• InjuryJun 27, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A NON-ABBOTT WIRE WAS INSERTED INTO THE INTRODUCER AND THERE WAS BLOOD LEAKING FROM THE VALVE OF THE INTRODUCER. THE PATIENT LOST A LARGE AMOUNT OF BLOOD BUT NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: Blood Loss

  MAUDE report 8739137 ↗
• InjuryJun 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE VALVE OF THE INTRODUCER. THE PROCEDURE WAS COMPLETED WITH THE SAME SHEATH. THE PATIENT WAS TREATED WITH PACKED BLOOD CELLS DUE TO LOW HEMOGLOBIN AND IS IN STABLE CONDITION.

  Patient problems: Blood Loss

  MAUDE report 8708505 ↗
• MalfunctionJun 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A BLOOD LEAK WAS NOTED AT THE VALVE OF THE INTRODUCER. THE PATIENT EXPERIENCED LOW VALUE OF HEMOGLOBIN, BUT NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682425 ↗
• MalfunctionJun 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, THE SHEATH STARTED LEAKING FROM THE HEMOSTASIS VALVE. SALINE WAS INJECTED CONTINUALLY TO REDUCE THE BLEEDING. THE LEAK BECAME WORSE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682372 ↗
• MalfunctionMay 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639850 ↗
• MalfunctionMay 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE TAVR PROCEDURE AT THE ENTRY SITE IN THE FEMORAL ARTERY, THERE WAS BLOOD LEAKING FROM THE VALVE AFTER THE DILATOR WAS REMOVED. THE INTRODUCER STAYED IN SITU DURING THE WHOLE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613359 ↗
• InjuryMay 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, A LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. A BLOOD TRANSFUSION WAS REQUIRED TO STABILIZE THE PATIENT.

  Patient problems: Blood Loss

  MAUDE report 8605708 ↗
• MalfunctionApr 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE THE ULTIMUM SHEATH WAS FOUND TO BE LEAKING. THE PROCEDURE WAS FINISHED WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8551995 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER RETRIEVAL OF THE INTRODUCER, A DISSECTION WAS FOUND AT THE INTRODUCTION SITE OF THE EXTERNAL ILIAC ARTERY. TEARS AND DEFORMATION WERE FOUND ON THE SHEATH OF THE DEVICE. THE ISSUE WAS RESOLVED BY PLACING A STENT OVER THE AFFECTED AREA.

  Patient problems: Vascular Dissection

  MAUDE report 8471450 ↗
• MalfunctionMar 27, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTASIS VALVE WAS LEAKING BLOOD. THERE WERE NO ADVERSE CONSEQUENCES DUE TO THE LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457415 ↗
• MalfunctionMar 20, 2019Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  WHILE REMOVING THE SHEATH, THE YELLOW CAP DETACHED AND HAD TO BE HELD IN PLACE TO PREVENT FURTHER BLOOD LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8437865 ↗
• MalfunctionFeb 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE DEPLOYMENT OF PORTICO TAVI, IT WAS NOTED THAT THE YELLOW CAP ON TOP OF THE 19F ULTIMUM HEMOSTASIS INTRODUCER WAS DETACHED AND BLOOD WAS LEAKING FROM THAT SITE. THE INTRODUCER WAS ABLE TO BE MANIPULATED IN ORDER TO COMPLETE THE PROCEDURE. A HIGHER BLOOD LOSS THAN NORMAL WAS EXPERIENCED BY THE PATIENT, BUT NO INTERVENTIONS WERE NEEDED TO REPLENISH THE LOSS OF BLOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354857 ↗
• MalfunctionFeb 8, 2019Material Separation; Material Separation

  WHILE REMOVING THE DELIVERY SYSTEM FROM THE ULTIMUM SHEATH, A PORTION OF THE HEMOSTASIS VALVE SEPARATED FROM THE SHEATH WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8321361 ↗
• MalfunctionJan 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  TOWARDS THE END OF THE TAVI PROCEDURE, WHILE THE DELIVERY SYSTEM WAS BEING REMOVED FROM THE PATIENT, THROUGH A 19F ULTIMUM SHEATH, THE INTRODUCER¿S VALVE THAT PREVENTS BACK FLOW OF BLOOD BROKE. THERE WAS BLEEDING FROM THE FEMORAL ARTERY. THE PROBLEM WAS IDENTIFIED AND THE BLEEDING WAS STOPPED BY APPLYING MANUAL PRESSURE AND INSERTING A NEW SHEATH. A HEMATOMA DEVELOPED IN THE ACCESS SITE, WHICH RESOLVED WITH 20 MINUTES OF MANUAL PRESSURE POST PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 8273845 ↗
• MalfunctionOct 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PORTICO PROCEDURE, THE VALVE OF THE ULTIMUM EV HEMOSTASIS INTRODUCER WAS LEAKING BLOOD. THE PORTICO VALVE WAS IMPLANTED WITHOUT ANY COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITHOUT USING ANOTHER ULTIMUM EV HEMOSTASIS INTRODUCER. 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 7996787 ↗
• InjuryAug 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AFTER SUCCESSFUL IMPLANTATION OF THE ULTIMUM EV HEMOSTASIS INTRODUCER, THE ULTIMUM SHEATH WAS REMOVED FROM THE ART. FEMORALIS. THE RINSE ARM OF THE SHEATH HAD DETACHED ITSELF FROM THE LOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7774708 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A SUCCESSFULL PORTICO IMPLANT, THE ULTIMUM 19F WAS REMOVED. AN ANGIO CONTROL HAS SHOWED A COMPLETE OCCLUSION OF THE LEFT CFA. A TEA AND AN ARTERY RECONSTRUCTION WITH A BIOCOMPATIBLE TISSUE WAS PERFORMED. AN ANGIO POST INTERVENTION SHOWED A LEFT CFA STENOSIS: A PTA WAS PERFORMED WITH A 7 MM BALLOON WITH GOOD FINAL RESULT.

  Patient problems: Occlusion; Stenosis; Vascular Dissection

  MAUDE report 7774698 ↗