Fast-Cath™ 406787Recalls & reported problems
St. Jude Medical, Inc. · Hemostasis Introducer · Class 2
Data updated Oct 13, 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 05414734011778), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
- 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.
InjuryAug 28, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation
DURING AN ENDOMYOCARDIAL BIOPSY PROCEDURE, A PIECE OF THE SHEATH DETACHED REQUIRING SURGERY FOR REMOVAL. THE SHEATH WAS INSERTED IN THE RIGHT VENTRICLE AND AN ENDOMYOCARDIAL BIOPSY WAS PERFORMED USING THE SHEATH WITHOUT DIFFICULTY. AFTER THIS, A 0.035 J WIRE WAS PLACED IN THE SHEATH, THE SHEATH WAS PULLED DOWN TO THE ILIAC VEIN AND THEN THE FEMORAL VEIN. AT THE GROIN, TENSION WAS NOTED ON THE SHEATH. THE SHEATH WAS REMOVED WITH A MODERATE AMOUNT OF FORCE. THE DISTAL 6MM OF THE SHEATH, BROKE OFF AS THE SHEATH AND WIRE WERE REMOVED. IT WAS UNCLEAR WHETHER THE DETACHED PORTION OF THE SHEATH WAS INTRAVASCULAR OR EMBEDDED IN THE SUBCUTANEOUS TISSUE. A CUTDOWN PROCEDURE WAS PERFORMED WITH MANIPULATION OF THE FEMORAL VESSEL AND THE SHEATH TIP EMBOLIZED TO THE DISTAL SEGMENT LEFT UPPER LUNG LOBE. IT WAS DECIDED TO LEAVE THE SHEATH TIP IN PLACE RATHER THAN REMOVE IT. THERE HAVE BEEN NO ISSUES OR COMPLICATIONS FOR THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20091265 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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