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Cook G55493Recalls & reported problems

William A. Cook Australia Pty. Ltd. · Ovum Aspiration Needle, Single Lumen · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002554931), received between Jul 24, 2023 and Aug 2, 2023 — classified as 4 injuries.

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

  • Adverse Event Without Identified Device or Use Problem4

Patient problems

  • Hemorrhage/Blood Loss/Bleeding4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EXCESSIVE BLEEDING AFTER USING 2 NEEDLES (1 PATIENT).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 17442721 ↗
  • InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EXCESSIVE BLEEDING AFTER USING 2 NEEDLES (1 PATIENT).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 17442719 ↗
  • InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EXCESSIVE BLEEDING AFTER USING 2 NEEDLES (1 PATIENT).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 17386258 ↗
  • InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EXCESSIVE BLEEDING AFTER USING 2 NEEDLES (1 PATIENT).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 17386163 ↗

Other NEEDLE, ASSISTED REPRODUCTION devices

All NEEDLE, ASSISTED REPRODUCTION devices →

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