Fast-Cath™ 406303Recalls & reported problems
St. Jude Medical, Inc. · HEMOSTASIS INTRODUCER · Class 2
All models of Fast-Cath (71)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Fast-Cath hemostasis introducer is a sheath used to access blood vessels during catheter procedures. The 226 reports mostly describe components assembled incorrectly, with some reporting blood or fluid leaking from the valve. The reports include 2 injuries and no deaths. One recall, started in December 2019 and now closed, concerns devices containing a smaller sheath and dilator than labeled.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 226
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 05414734203906), received between Oct 25, 2019 and Jan 22, 2026 — classified as 2 injuries, 224 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (218 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Dec 9, 2019Terminated
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Z-0783-2020 · Root cause: Packaging · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Misassembled218
- Fluid/Blood Leak6
- Fitting Problem2
- Difficult to Insert1
Patient problems
- No Consequences Or Impact To Patient135
- No Patient Involvement84
- No Clinical Signs, Symptoms or Conditions6
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 226 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH VALVE WAS LEAKING BLOOD. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147241 ↗MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE AF PROCEDURE, THE SHEATH WAS INSERTED INTO THE FEMORAL VEIN AND THE VALVE WAS NOTED TO BE RIPPED, AND SALINE LEAKED. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22821869 ↗MalfunctionJul 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, FLUID LEAKED FROM THE INTRODUCER VALVE WHEN FLUSHING. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19652438 ↗MalfunctionJun 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE SHEATH. WHEN THE SHEATH WAS INSERTED INTO THE FEMORAL VEIN, IT WAS NOTED THAT THERE WAS BLEED BACK. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19456107 ↗MalfunctionJun 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK OCCURRED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19448536 ↗MalfunctionNov 11, 2021Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12795882 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507862 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507847 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507845 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507836 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507821 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507815 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507810 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507808 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507805 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507797 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507777 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507773 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507771 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507766 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507763 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507761 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507748 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507723 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
AFTER A PROCEDURE THE CUSTOMER DECIDED TO RETURN 129 UNUSED DEVICES FOR CONTINUED INSERTION DIFFICULTIES. IT WAS LATER DETERMINED THAT THE INTRODUCERS WERE 12F INSTEAD OF THE 14F AS LABELED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9507722 ↗
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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 · each recall links to the FDA recall notice
- 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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