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Cook G21859Recalls & reported problems

Cook Incorporated · Disposable Varices Injector · 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 00827002218598), received between Jun 6, 2016 and Jun 6, 2016 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 6, 2016Material Separation; Material Separation

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK DISPOSABLE VARICES INJECTOR. THE CATHETER SEPARATED [UNKNOWN LOCATION] AND DID NOT PULL BACK INTO THE NEEDLE CORRECTLY. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5700586 ↗

Other endoscopic injection needle, gastroenterology-urology devices

All endoscopic injection needle, gastroenterology-urology devices →

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