ULTIMUM™ C407595Recalls & 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
- 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 05414734025690), received between Jan 14, 2021 and Jan 14, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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.
Most reported problems
Device problems
- Material Too Rigid or Stiff1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
AT THE END OF THE INTERVENTIONAL CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE, THE GUIDEWIRE WAS PUSHED OUT TO PULL OUT THE VASCULAR SHEATH AND DURING THE PROCESS, THE GUIDEWIRE PUNCTURED A BLOOD VESSEL. BLOOD EXTRAVASATION AND SUBCUTANEOUS CONGESTION WERE NOTED. COMPRESSION AND A VASCULAR SUTURE DEVICE WERE USED TO STABILIZE THE PATIENT. THE GUIDEWIRE WAS NOTED TO BE TOO HARD.
Patient problems: Vascular Dissection
MAUDE report 11169502 ↗
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- 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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