Fast-Cath™ 406133Recalls & reported problems
St. Jude Medical, Inc. · 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 05414734009843), received between Apr 17, 2020 and Apr 17, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2020Material Fragmentation; Difficult to Remove; Material Fragmentation; Difficult to Remove
DURING A LEFT ATRIAL FLUTTER ABLATION PROCEDURE, RESISTANCE WAS NOTED WHEN INSERTING THE DILATOR INTO THE INTRODUCER. WHEN ATTEMPTING TO WITHDRAW THE INTRODUCER IN A TWISTING MOTION, THE DISTAL END OF THE SHEATH SEPARATED APPROXIMATELY 1 CM FROM THE PROXIMAL END. THE PROXIMAL END WAS UNABLE TO BE RETRIEVED FROM THE PATIENT SO SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE REMAINING PORTION OF THE INTRODUCER. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9971578 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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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 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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