ULTIMUM™ 407831Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05414734008808), received between Nov 24, 2021 and Nov 24, 2021 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (40 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 16, 2021Terminated

   As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.

   Z-0420-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869324 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED ((B)(4) UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869311 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869255 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869250 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869246 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869245 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869243 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869239 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869238 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED ((B)(4)UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869235 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869211 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869201 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869055 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED ((B)(4)). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869046 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869043 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869039 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869038 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869036 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869021 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869020 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869018 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869015 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868895 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868889 ↗
• MalfunctionNov 24, 2021Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION, WHEN THE SHEATH WAS FLUSHED AND THE DILATOR WAS INSERTED INTO THE SHEATH, IT WAS NOTED THAT THE SHEATH WAS LONGER THAN THE DILATOR. THE INTRODUCER WAS REPLACED, AND THE SAME ISSUE WAS NOTED. ANOTHER INTRODUCER OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. ALL BOXES OF LOT NUMBER 7748246 TO BE RETURNED (38 UNITS). THE USED DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868888 ↗