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ULTIMUM™ 407695Recalls & reported problems

St. Jude Medical, Inc. · Hemostasis Introducer · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734054751), received between May 24, 2019 and May 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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

  • Material Fragmentation1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 24, 2019Material Fragmentation; Material Fragmentation

    DURING A PULMONARY VEIN ISOLATION USING A NON-SJM 3D MAPPING SYSTEM, THE LINER FRACTURED IN THE PROXIMAL PORTION OF THE DEVICE AND EMBOLIZED THE PATIENT'S PULMONARY BED, WHICH FORCED THE PROCEDURE TO BE INTERRUPTED. A PERCUTANEOUS REMOVAL FOR THE INTRODUCER WAS PERFORMED. A GUIDEWIRE AND INTRODUCER WERE PASSED THROUGH FEMORAL ACCESS TO TRAP THE PORTION AND REMOVE IT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8642124 ↗

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.