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Flexi-Tip G14015Recalls & reported problems

Cook Incorporated · Flexi-Tip Ureteral Catheter (Right) · Class 2

All models of Flexi-Tip (7)

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 00827002140158), received between Apr 12, 2018 and Apr 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

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.

  • MalfunctionApr 12, 2018Material Separation

    THE COMPLAINANT REPORTED THAT THE FLEXI TIP WAS LOOSE FROM THE FLEXI-TIP URETERAL CATHETERS (QUANTITY 2) WHILE THE DEVICES WERE IN THE PACKAGING. IT WAS FURTHER NOTED THAT THE DEVICES WERE SEPARATED. THERE WAS NO REPORTED IMPACT TO THE PATIENT OR END USER AS A RESULT OF THE PRODUCT PROBLEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7426608 ↗

Other CATHETER, UROLOGICAL devices

All CATHETER, UROLOGICAL devices →

Sources and updates

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