Flexor G12660Recalls & reported problems
Cook Incorporated · Flexor, Radial Introducer Sheath Set · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002126602), received between Dec 13, 2016 and Dec 23, 2016 — classified as 3 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
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED DURING A RADIAL ACCESS PROCEDURE THE VALVE WAS LEAKING. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES REPORTED. 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 6202398 ↗MalfunctionDec 15, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A VALVE WAS LEAKING WHEN PUNCTUATED DURING A RIGHT RADIAL ACCESS PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 6178359 ↗MalfunctionDec 13, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED BY MATERIALS MANAGEMENT, A NOTE WAS PLACED WITH THE DEVICE THAT STATES "WAS LEAKING AROUND THE SHEATH." ADDITIONAL INFORMATION HAD BEEN REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6170079 ↗
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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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