Fast-Cath™ 406143Recalls & reported problems
St. Jude Medical, Inc. · Class 2
All models of Fast-Cath (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Fast-Cath introducer catheter is a sheath-and-dilator set used to place catheters. The 69 reports all describe a packaging mix-up in which the units inside were a smaller size than the packaging stated, so the catheter would not pass through the sheath and procedures had to continue with other supplies. No deaths and no injuries were reported. One recall, started in December 2019 and now closed, covered three lots packed with the wrong size.
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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05414734014212), received between Dec 16, 2019 and Dec 22, 2019 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (69 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 18, 2026.
Recalls naming this device
- Dec 9, 2019Class IITerminated
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Z-0789-2020 · Root cause: Packaging · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Misassembled69
Patient problems
- No Patient Involvement66
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508594 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508107 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508104 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508100 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508097 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508096 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9508095 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500959 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500885 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500867 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500828 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500683 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500612 ↗MalfunctionDec 20, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500371 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500076 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9500028 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9499906 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
PRIOR TO THE PROCEDURE, THE SHEATH WAS NOTED TO BE AN 8FR, WHEN THE PACKAGING READ 8.5FR. ELEVEN SHEATHS WERE RETURNED UNOPENED.
Patient problems: No Patient Involvement
MAUDE report 9499492 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9498542 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9498412 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9498406 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9498237 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9498225 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 9498071 ↗MalfunctionDec 19, 2019Component Misassembled; Component Misassembled
DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE SHEATH. ANOTHER PACKAGE WAS OPENED BUT THE CATHETER COULD NOT PASS THOUGH THE SHEATH AGAIN. THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE INTRODUCER WAS AN 8FR INTRODUCER BUT THE PACKAGING INDICATED 8.5FR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES WITHOUT IMAGING. THE DEVICES USED WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. AN ADDITIONAL 26 UNITS IN TOTAL WERE FOUND TO CONTAIN 8F INTRODUCERS IN 8.5F PACKAGING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9497990 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page