ENGAGE™ C408527Recalls & reported problems
St. Jude Medical, Inc. · Introducer; 6F-ACT · Class 2
All models of ENGAGE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734053532), received between Jun 7, 2023 and Jun 7, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.
Most reported problems
Device problems
- Fluid/Blood Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING THE CORONARY ANGIOGRAPHY PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE VALVE. DEFORMATION OF THE COUNTERSINK WAS ALSO NOTED. THE DEVICE WAS REPLACED WITH ANOTHER INTRODUCER TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17077649 ↗MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING THE CORONARY ANGIOGRAPHY PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE VALVE. DEFORMATION OF THE COUNTERSINK WAS ALSO NOTED. THE DEVICE WAS REPLACED WITH ANOTHER INTRODUCER TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17077644 ↗MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING THE CORONARY ANGIOGRAPHY PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE VALVE. DEFORMATION OF THE COUNTERSINK WAS ALSO NOTED. THE DEVICE WAS REPLACED WITH ANOTHER INTRODUCER TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17077638 ↗
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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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