Skip to content

Cook G17590Recalls & reported problems

Cook Incorporated · Cook, Balloon Cervical Cannula · Class 2

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 00827002175907), received between Dec 6, 2018 and Dec 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Deflation Problem1

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.

  • MalfunctionDec 6, 2018Deflation Problem

    THE COMPLAINANT REPORTED THAT THE DUAL HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON INFLATED BUT WOULD NOT DEFLATE. THE PHYSICIAN USED ANOTHER BALLOON TO PROCEED WITH THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8138654 ↗

Other INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES) devices

All INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.