Flexor G35601Recalls & 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
- 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 00827002356016), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Blood Loss1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED, DURING A CARDIAC CATHETER EXAMINATION THE HEMOSTATIC VALVE OF THE FLEXOR RADIAL ACCESS SET WAS LEAKING DURING USAGE, BLOOD WAS SPRAYING OUT. PER ADDITIONAL INFORMATION, THE NURSE REPORTED THAT THE BLOOD SPLATTERED OUT AFTER THE WIRE WAS REMOVED. THE VALVE STOPPED WORKING AND THE PATIENT LOST ABOUT 10 ML OF BLOOD. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 6412979 ↗
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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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