Fast-Cath™ 406102Recalls & reported problems
St. Jude Medical, Inc. · Class 2
- 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 05414734016254), received between Jan 13, 2025 and Jan 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionJan 13, 2025Material Separation; Material Separation
POST PROCEDURE, THE SIDE PORT OF THE SHEATH DETACHED. ON (B)(6) 2025, THE SHEATH WAS INSERTED INTO THE PATIENT FOR AN AMI PROCEDURE. A TEMPORARY PACING CATHETER WAS PLACED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL IN THE WARD. SIX DAYS POST PROCEDURE, IT WAS NOTED THAT THE SIDE PORT HAD DETACHED FROM THE SHEATH. SINCE SPONTANEOUS PULSE WAS NOTED, THE TEMPORARY PACING CATHETER AND SHEATH WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139469 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.