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ULTIMUM™ 407688Recalls & reported problems

St. Jude Medical, Inc. · HEMOSTASIS INTRODUCER · Class 2

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734021999), received between May 18, 2021 and Jun 29, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak7

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    RELATED MANUFACTURING REF: 3005334138-2021-00428. DURING A WATCHMAN PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE HEMOSTATIC VALVE LEAKS FROM THE VERY BEGINNING OF THE CASE BEFORE ANY CATHETERS ARE INTRODUCED. THE PATIENT WAS STABLE. .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12083437 ↗
  • MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    RELATED MANUFACTURING REF: 3005334138-2021-00429. DURING A WATCHMAN PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE HEMOSTATIC VALVE LEAKS FROM THE VERY BEGINNING OF THE CASE BEFORE ANY CATHETERS ARE INTRODUCED. THE PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12083411 ↗
  • MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    RELATED MANUFACTURING REF: 3005334138-2021-00426. DURING A WATCHMAN PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE HEMOSTATIC VALVE LEAKS FROM THE VERY BEGINNING OF THE CASE BEFORE ANY CATHETERS ARE INTRODUCED. THE PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12083342 ↗
  • MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    RELATED MANUFACTURING REF: 3005334138-2021-00427. DURING A WATCHMAN PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE HEMOSTATIC VALVE LEAKS FROM THE VERY BEGINNING OF THE CASE BEFORE ANY CATHETERS ARE INTRODUCED. THE PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12083249 ↗
  • MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    RELATED MANUFACTURING REF: 3005334138-2021-00424. DURING A WATCHMAN PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE HEMOSTATIC VALVE LEAKS FROM THE VERY BEGINNING OF THE CASE BEFORE ANY CATHETERS ARE INTRODUCED. THE PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12083210 ↗
  • MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    RELATED MANUFACTURING REF: 3005334138-2021-00425. DURING A WATCHMAN PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE HEMOSTATIC VALVE LEAKS FROM THE VERY BEGINNING OF THE CASE BEFORE ANY CATHETERS ARE INTRODUCED. THE PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12083188 ↗
  • MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE INTRODUCER WAS NOTED TO BE LEAKING. THERE IS NO FURTHER INFORMATION AVAILABLE DESPITE MAKING SEVERAL ATTEMPTS.

    Patient problems: Insufficient Information

    MAUDE report 11840773 ↗

Other INTRODUCER, CATHETER devices

All INTRODUCER, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.