Fast-Cath™ 406553Recalls & reported problems
St. Jude Medical, Inc. · Transseptal Guiding Introducer · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734203258), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Flaked1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Flaked; Difficult to Insert; Flaked; Difficult to Insert
DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER A NEEDLE WAS INSERTED INTO THE SHEATH IN THE PATIENT, THE SHEATH WAS GRINDING AGAINST THE NEEDLE. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE NEEDLE WAS NOT RESHAPED, AND THE STYLET WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19131161 ↗
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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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