ULTIMUM™ 407834Recalls & reported problems
St. Jude Medical, Inc. · Hemostasis Introducer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734015974), received between Mar 1, 2023 and Mar 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, AN AIR LEAK AND A BLOOD LEAK WAS NOTED. THE INTRODUCER WAS REPLACED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATH WAS USED FOR THE PUNCTURE AND BLOOD-RETURN WAS CONFIRMED. WHEN THE SIDE PORT WITH THE THREE-WAY STOPCOCK WAS USED, THERE WAS AIR LEAKAGE NOTED FROM IT AND BLOOD BLEEDING FROM THE HUB. THE INTRODUCER WAS REPLACED TO COMPLETE THE PROCEDURE. PATIENT'S CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16459734 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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