Fast-Cath™ 406969Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734203579), received between Apr 21, 2021 and Nov 20, 2025 — classified as 2 malfunctions.
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
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Material Puncture/Hole; Material Puncture/Hole
THIS REPORT IS TO ADVISE OF A MATERIAL PUNCTURE FOUND IN THE SHEATH DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601649 ↗MalfunctionApr 21, 2021Material Separation; Material Separation
DURING THE PROCEDURE, AFTER PERFORMING THE TRANSSEPTAL PUNCTURE AND WHEN REMOVING THE SHEATH FROM THE PATIENT TO REPLACE IT WITH A NON-ABBOTT CRYO SHEATH, THE BODY OF THE SHEATH SEPARATED FROM THE VALVE. THE SHEATH BODY, VALVE, AND DILATOR WERE ALL REMOVED OVER A WIRE USING STANDARD EXCHANGE TECHNIQUE. NO INTERVENTION WAS REQUIRED AND ALL THE PIECES OF THE DEVICE WERE ACCOUNTED FOR. THE PLANNED SHEATH EXCHANGE THEN OCCURRED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11700304 ↗
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- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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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