Fast-Cath™ 406120Recalls & reported problems
St. Jude Medical, Inc. · Class 2
All models of Fast-Cath (71)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734008266), received between Aug 8, 2020 and Jun 13, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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
- Material Separation2
- Fluid/Blood Leak1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURING REF: 3005334138-2023-00265. UPON REMOVAL OF THE HEMOSTASIS INTRODUCER, THE VALVE TO THE INTRODUCER DID NOT SEAL CLOSE AS EXPECTED WHICH ALLOWED BLEEDING FROM THE INTRODUCER. THE HEMOSTASIS INTRODUCER WAS IMMEDIATELY EXCHANGED FOR A SECOND INTRODUCER OF THE SAME MODEL AND LOT. THE SECOND INTRODUCER VALVE WOULD NOT SEAL EITHER, ALLOWING FOR BLEEDING. THE SECOND SHEATH WAS THEN EXCHANGED FOR A NON ABBOTT INTRODUCER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17118395 ↗MalfunctionFeb 24, 2022Material Separation; Material Separation
DURING THE PROCEDURE, THE SHEATH BROKE UPON REMOVAL FROM THE PATIENT AND APPROXIMATELY HALF THE SHEATH REMAINED IN THE THE VEIN (WITH A SMALL PORTION STICKING OUT). A CUT DOWN PROCEDURE WAS PERFORMED AND THE DETACHED PORTION WAS RETRIEVED WITH NO ADVERSE EVENT TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 13592395 ↗InjuryAug 8, 2020Material Separation; Material Separation
DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, THE SHEATH SPLIT INSIDE THE PATIENT'S ANATOMY. THE DEVICE WAS REMOVED OVER A WIRE. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A LARGER SHEATH.
Patient problems: Perforation
MAUDE report 10382995 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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 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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