Fast-Cath™ 406902Recalls & reported problems
St. Jude Medical, Inc. · Transseptal Guiding Introducer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734203456), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Arrhythmia1
- Death1
- Respiratory Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE: 3008452825-2020-00015, 3005334138-2020-00019, 3008452825-2020-00016, 3008452825-2020-00017, 3008452825-2020-00018, 3008452825-2020-00019, 3005334138-2020-00021. DURING THE MAPPING OF A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, FOLLOWING MAPPING OF THE RIGHT AND LEFT VENTRICLE, THE PATIENT EXPERIENCED RESPIRATORY FAILURE AND PULSELESS ELECTRICAL ACTIVITY. AN IMMEDIATE CARDIAC MASSAGE WAS PERFORMED, WITHOUT THE RESTORATION OF NATURAL HEART CONTRACTION. THERE WAS NO PERICARDIAL EFFUSION VISIBLE WITH THE INTRACARDIAC ECHO AND THE PROCEDURE WAS INTERRUPTED BEFORE THE ABLATION. THE PATIENT EXPIRED. THE CAUSE OF THE RESPIRATORY FAILURE AND SUBSEQUENT DEATH IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.
Patient problems: Arrhythmia; Death; Respiratory Failure
MAUDE report 9590539 ↗
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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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