Check-Flo G07564Recalls & reported problems
Cook Incorporated · Check-Flo Introducer Set · Class 2
All models of Check-Flo (19)
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 00827002075641), received between Oct 10, 2017 and Oct 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Leak/Splash1
- Physical Resistance1
Patient problems
- 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.
MalfunctionOct 10, 2017Leak/Splash; Physical Resistance; Difficult to Advance
IT WAS REPORTED DURING THE PATIENT'S PARAVALVULAR LEAK REPAIR PROCEDURE, AFTER INTRODUCING THE LOADER INTO THE SHEATH, THE PUSHER WAS UNABLE TO BE ADVANCED INTO THE SHEATH. RESISTANCE WAS FELT AND COULD NOT BE RESOLVED. AS A RESULT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. PER THE DEVICE EVALUATION, THE TIP OF THE SHEATH WAS FOLDED OVER ON ITSELF AND NICKED IN SEVERAL PLACES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6935074 ↗
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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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