Flexor G35604Recalls & reported problems
Cook Incorporated · Flexor, Radial Access Set · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002356047), received between Mar 4, 2015 and Mar 27, 2017 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 reports).
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.
Most reported problems
Device problems
- Leak/Splash3
- Unraveled Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Blood Loss1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2017Unraveled Material; Unraveled Material
IT WAS REPORTED THAT AS THE WIRE CAME OUT OF NEEDLE IT STARTED TO UNRAVEL. NO HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED BUT HAS NOT BEEN RECEIVED AS IT IS UNKNOWN WHO THE OPERATOR OF THE DEVICE WAS AT THE TIME OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6435576 ↗MalfunctionDec 27, 2016Leak/Splash; Leak/Splash
DURING A PERCUTANEOUS CORONARY INTERVENTION VIA RADIAL APPROACH, THE HAEMOSTATIC VALVE WAS LEAKING BLOOD WHEN THE DILATOR WAS REMOVED. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE CONTINUED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6206435 ↗MalfunctionApr 23, 2015Leak/Splash
DURING A PCI VIA RADIAL ARTERY PROCEDURE, THE SHEATH WAS INSERTED AND IT WAS NOTED THAT THE SHEATH VALVE BEGAN TO LEAK DURING THE PROCEDURE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 4731319 ↗MalfunctionMar 4, 2015Leak/Splash
DURING A PCI VIA RADIAL ARTERY ACCESS PROCEDURE, AFTER THE SHEATH WAS INSERTED, THE VALVE BEGAN TO LEAK. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 4586882 ↗
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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
- 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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