ULTIMUM™ 407655Recalls & reported problems
St. Jude Medical, Inc. · HEMOSTASIS INTRODUCER · Class 2
All models of ULTIMUM (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734011259), received between Sep 6, 2019 and May 15, 2025 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING A PROCEDURE, WITH A CATHETER INSERTED INTO THE SHEATH, A LEAK WAS NOTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029108 ↗MalfunctionSep 6, 2019Material Fragmentation; Material Fragmentation
DURING THE PROCEDURE, A PIECE OF THE DEVICE BROKE OFF AFTER BEING INSERTED INTO THE PATIENT'S ANATOMY. THE FEMORAL VEIN WAS DIFFICULT TO PUNCTURE AND A STIFF GUIDEWIRE WAS USED TO INTRODUCE THE INTRODUCER. WHEN THE DILATOR WAS REMOVED FROM THE PATIENT, THE TIP WAS NOTED TO BE SPLIT AND BROKEN AND A PIECE OF THE DEVICE WAS MISSING. THE MISSING PIECE WAS UNABLE TO BE FOUND AND IT WAS UNKNOWN IF THE DEVICE BROKE INSIDE THE PATIENT'S ANATOMY. THE DEVICE WAS REPLACED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8971537 ↗
Other INTRODUCER, CATHETER devices
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- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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