Fast-Cath™ 406182Recalls & 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
- 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 05414734012904), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Material Puncture/Hole; Material Puncture/Hole
THE FOLLOWING EVENT WAS RECEIVED FROM A VOLUNTARY MEDWATCH REPORT: THE PATIENT WAS ON THE CARDIAC TREATMENT UNIT IN (B)(6) 2025. WHILE PREPARING TO REMOVE THE SHEATH FROM THE GROIN, THE NURSE NOTED BLEEDING FROM THE GROIN. UPON REMOVAL OF THE SHEATH, A HOLE WAS NOTED; THE BLEEDING FROM THE GROIN WAS COMING FROM THE HOLE IN THE SHEATH. MANUAL COMPRESSION WAS APPLIED FOR 40 MINUTES TO STOP THE BLEEDING. THE PATIENT WAS DISCHARGED LATER THAT NIGHT WITH NO FURTHER ISSUES. THE SHEATH HAD BEEN USED FOR APPROXIMATELY 2 HOURS THAT DAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23640597 ↗
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- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- 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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