Fast-Cath™ 406350Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067000767), received between Jun 12, 2023 and Jun 12, 2023 — 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. How this data works · Data updated Oct 13, 2026.
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.
MalfunctionJun 12, 2023Material Separation; Material Separation
AT THE END OF AN ATRIAL FIBRILLATION PROCEDURE, WHEN THE INTRODUCER POSITIONED IN THE FEMORAL VEIN WAS REMOVED, IT WAS NOTED THAT THE 10 CM DISTAL PART WAS DETACHED AND REMAINED IN THE VESSEL. A SURGICAL PROCEDURE WAS NEEDED TO REMOVE THE DETACHED PIECE WITH NO ADVERSE CONSEQUENCES. THE PROCEDURE WAS EXTENDED BY 20 MINUTES DUE TO THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 17106329 ↗
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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 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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