Flexor G10882Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Balkin Up & Over, Contralateral Design · 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 00827002108820), received between May 16, 2017 and May 16, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- 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.
MalfunctionMay 16, 2017Bent; Break
DURING AN UNKNOWN PROCEDURE, ACCESS WAS GAINED FROM THE RIGHT FEMORAL ARTERY IN ORDER TO ADVANCE THE DEVICE TO THE LESION CONTRALATERALLY. AFTER EXPERIENCING STRONG RESISTANCE WHEN ADVANCING THE DEVICE OVER A PLACED WIRE GUIDE, THE USER CHECKED THE DEVICE AND FOUND THAT THE DEVICE TIP WAS "DAMAGED" (CURLED UP). UPON FURTHER REVIEW OF THE DEVICE, IT WAS CONFIRMED THAT THE SHEATH TUBING WAS CURLED AT THE TRANSITION TO THE DILATOR. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORT OF ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6569475 ↗
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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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