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Cook G07411Recalls & reported problems

Cook Incorporated · Percutaneous Entry Thinwall Needle One-Part · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002074118), received between Apr 17, 2017 and Apr 17, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryApr 17, 2017Crack; Crack

    IT WAS REPORTED THAT THE HUB CRACKED DURING A RIGHT BUTTOCK SCLEROTHERAPY OF A VENOUS MALFORMATION PROCEDURE. THE TREATMENT HAD TO BE CHANGED. A CLOT WAS CREATED AT THE SITE OF THE FIRST NEEDLE AND ACCESS WAS CREATED WITH ANOTHER NEEDLE TO REDUCE THE RETURN OF BLOOD AND MEDICINE. NO UNINTENDED SECTION OF THE DEVICE REMAINS INSIDE THE PATIENT¿S BODY.

    Patient problems: No Code Available

    MAUDE report 6498072 ↗

Other Trocar devices

All Trocar devices →

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