ENGAGE™ C408501Recalls & reported problems
St. Jude Medical, Inc. · Introducer; 5F-ACT · Class 2
All models of ENGAGE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734052795), received between May 8, 2025 and May 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2025Material Separation; Material Separation
ON (B)(6) 2025 THE PATIENT UNDERWENT A SUCCESSFUL EMBOLIZATION OF THE RIGHT BRONCHIAL ARTERY IN THE CONTEXT OF LUNG BLEEDING AT INTERVENTIONAL RADIOLOGY. ON (B)(6) 2025, DURING THE REMOVAL OF A FEMORAL ARTERIAL SHEATH USING FEMOSTOP IN THE INTENSIVE CARE UNIT, A PIECE OF THE CATHETER BROKE OFF. A CT ANGIOGRAM CONFIRMED THAT A PIECE OF THE CATHETER REMAINED AT THE LEVEL OF THE COMMON FEMORAL ARTERY WITHOUT IMPACT ON BLOOD FLOW. IN CONSULTATION WITH VASCULAR SURGERY, THIS PIECE WAS SURGICALLY REMOVED UNDER LOCAL ANESTHESIA ON (B)(6) 2025.
Patient problems: Foreign Body In Patient
MAUDE report 21987684 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
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- 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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