Check-Flo G12896Recalls & reported problems
Cook Incorporated · Extra Large Check-Flo Introducer · 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 00827002128965), received between Oct 24, 2017 and Oct 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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 24, 2017Break; Break
THE AREA REPRESENTATIVE REPORTED ON (B)(6) 2017, THAT AN UNSPECIFIED PROCEDURE WAS PERFORMED ON A (B)(6), MALE PATIENT. AS REPORTED, WHILE USING THE CHECK-FLO EXTRA LARGE INTRODUCER, THE END OF THE DILATOR BROKE OFF WHILE UNTHREADING OVER THE LUNDERQUIST WIRE. IT WAS REPORTED THAT NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY AND O ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6974434 ↗
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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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