ULTIMUMRecalls & reported problems across all models
St. Jude Medical, Inc. · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 150
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 1
We found 21 models of ULTIMUM by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 150 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2018 and Feb 26, 2026 — classified as 22 injuries, 128 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (73 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ULTIMUM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 16, 2021Terminated
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
Z-0420-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported ULTIMUM problems
Device problems
- Fluid/Blood Leak73
- Component Misassembled40
- Difficult to Insert8
- Adverse Event Without Identified Device or Use Problem7
- Material Separation7
- Backflow2
- Detachment of Device or Device Component2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- No Consequences Or Impact To Patient45
- Vascular Dissection4
- Blood Loss3
- Hemorrhage/Blood Loss/Bleeding3
- Foreign Body In Patient2
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
ULTIMUM models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ULTIMUM™ 407831INTRODUCER, CATHETER1 recall40 reports
- Ultimum™ C407699INTRODUCER, CATHETER30 reports
- ULTIMUM™ 407845INTRODUCER, CATHETER14 reports
- ULTIMUM™ 407832INTRODUCER, CATHETER9 reports
- ULTIMUM™ 407847INTRODUCER, CATHETER9 reports
- ULTIMUM™ 407843INTRODUCER, CATHETER8 reports
- ULTIMUM™ 407687INTRODUCER, CATHETER7 reports
- ULTIMUM™ 407688INTRODUCER, CATHETER7 reports
- ULTIMUM™ 407849INTRODUCER, CATHETER5 reports
- ULTIMUM™ 407694INTRODUCER, CATHETER5 reports
- ULTIMUM™ C407698INTRODUCER, CATHETER4 reports
- ULTIMUM™ 407844INTRODUCER, CATHETER2 reports
- ULTIMUM™ 407655INTRODUCER, CATHETER2 reports
- ULTIMUM™ 407838INTRODUCER, CATHETER1 report
- ULTIMUM™ 407848INTRODUCER, CATHETER1 report
- ULTIMUM™ 407833INTRODUCER, CATHETER1 report
- ULTIMUM™ 407834INTRODUCER, CATHETER1 report
- ULTIMUM™ 407856INTRODUCER, CATHETER1 report
- ULTIMUM™ C407597INTRODUCER, CATHETER1 report
- ULTIMUM™ C407595INTRODUCER, CATHETER1 report
- ULTIMUM™ 407695INTRODUCER, CATHETER1 report
Recent ULTIMUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Fluid/Blood Leak
DURING A TAVI PROCEDURE, WHILE ACCESSING THE FEMORAL ARTERY USING THE INTRODUCER AND A NON-ABBOTT GUIDEWIRE (LUNDERQUIST BY COOK MEDICAL), BLOOD LEAKED FROM THE HEMOSTASIS VALVE RESULTING IN SIGNIFICANT BLOOD LOSS. MANUAL COMPRESSION WITH GAUZE WAS HELD AT THE VALVE OF THE INTRODUCER. THE BLEEDING RESULTED IN A MARKED DECREASE IN THE PATIENT¿S HEMOGLOBIN LEVELS: ON (B)(6) 2026 HB: 13.8; ON (B)(6) 2026 HB: 11.9. NO INTERVENTION WAS ADMINISTERED TO TREAT THE DROP IN HEMOGLOBIN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24457559 ↗MalfunctionFeb 18, 2026Fluid/Blood Leak
DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, BLOOD LEAKED FROM THE SHEATH. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382291 ↗MalfunctionOct 17, 2025Fracture; Fracture
AT THE END OF THE PCI PROCEDURE, AFTER REMOVING THE SHEATH FROM THE PATIENT, THE DEVICE WAS NOTED TO BE FRACTURED AT THE BASE, BETWEEN THE HUB TO CATHETER TRANSITION. THE SHEATH WAS NOT EXCHANGED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23330439 ↗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 ↗MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PROCEDURE, A BLOOD LEAK OCCURRED. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751442 ↗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 ↗MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING A PERSISTENT TRUNCUS ARTERIOSUS PROCEDURE, PRIOR TO INSERTING ANYTHING INTO THE SHEATH, IT WAS DISCOVERED THAT BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091312 ↗InjuryJun 10, 2024Material Puncture/Hole; Material Puncture/Hole
DURING PAROXYSMAL PROCEDURE, THE STYLET BROKE THE PURGE LINE WHICH RESULTED IN PATIENT BLEEDING. THE DEVICE WAS EXCHANGED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19504734 ↗MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING THE RIGHT LEG PERIPHERAL ARTERIAL OCCLUSION DISEASE, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PAOD PTA) SURGERY, A FLUID LEAK OCCURRED. THE SHEATH WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL ARTERY. WHILE FLUSHING WITH NORMAL SALINE, IT WAS OBSERVED THAT THE HEMOSTASIS VALVE OF THE SHEATH WAS LEAKING. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18950496 ↗MalfunctionMar 11, 2024Material Puncture/Hole; Material Puncture/Hole
DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IT WAS NOTED THAT THERE WAS A HOLE IN THE SHEATH. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AT THE END OF THE PROCEDURE, EXOSEAL WAS ABOUT TO BE PERFORMED WHEN THE CLOSURE DEVICE WOULD NOT ADVANCE. THE SHEATH WAS EXCHANGED AND UPON REMOVAL A HOLE WAS OBSERVED. IT IS UNKNOWN IF THIS OCCURRED WHEN THE EXOSEAL WAS BEING INTRODUCED OR AT SOME OTHER POINT. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT INTRODUCER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT IS NOTED THAT THE AFFECTED SHEATH INSERTED WITHOUT ISSUE AND THE RIGHT COMMON FEMORAL ARTERY ANGIOGRAM LOOKED GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874162 ↗MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING A VASCULAR ANGIOPLASTY PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18646596 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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