ULTIMUM™ 407694Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734054737), received between Dec 9, 2024 and Dec 9, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (5 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. 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
- Difficult to Insert5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Difficult to Insert; Difficult to Insert
RELATED MANUFACTURING REF: 3005334138-2024-00526, 3005334138-2024-00528, 3005334138-2024-00529, 3005334138-2024-00530. DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED AND THE GUIDE CATHETER COULD NOT BE PASSED OVER THE VALVE. FOUR ADDITIONAL INTRODUCERS FROM THE SAME LOT WERE USED WHICH HAD THE SAME ISSUE. A NON ABBOTT INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20885676 ↗MalfunctionDec 9, 2024Difficult to Insert; Difficult to Insert
RELATED MANUFACTURING REF: (B)(4). DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED AND THE GUIDE CATHETER COULD NOT BE PASSED OVER THE VALVE. FOUR ADDITIONAL INTRODUCERS FROM THE SAME LOT WERE USED WHICH HAD THE SAME ISSUE. A NON ABBOTT INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20885321 ↗MalfunctionDec 9, 2024Difficult to Insert; Difficult to Insert
RELATED MANUFACTURING REF: 3005334138-2024-00527, 3005334138-2024-00528, 3005334138-2024-00529, 3005334138-2024-00530. DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED AND THE GUIDE CATHETER COULD NOT BE PASSED OVER THE VALVE. FOUR ADDITIONAL INTRODUCERS FROM THE SAME LOT WERE USED WHICH HAD THE SAME ISSUE. A NON-ABBOTT INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20883853 ↗MalfunctionDec 9, 2024Difficult to Insert; Difficult to Insert
RELATED MANUFACTURING REF: 3005334138-2024-00526, 3005334138-2024-00527, 3005334138-2024-00529, 3005334138-2024-00530. DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED AND THE GUIDE CATHETER COULD NOT BE PASSED OVER THE VALVE. FOUR ADDITIONAL INTRODUCERS FROM THE SAME LOT WERE USED WHICH HAD THE SAME ISSUE. A NON ABBOTT INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20883618 ↗MalfunctionDec 9, 2024Difficult to Insert; Difficult to Insert
RELATED MANUFACTURING REF: 3005334138-2024-00526, 3005334138-2024-00527, 3005334138-2024-00528, 3005334138-2024-00530. DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED AND THE GUIDE CATHETER COULD NOT BE PASSED OVER THE VALVE. FOUR ADDITIONAL INTRODUCERS FROM THE SAME LOT WERE USED WHICH HAD THE SAME ISSUE. A NON ABBOTT INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20883003 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- 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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