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
- 17G Wallace Single Lumen Oocyte Recovery Set ONS1733Coopersurgical, Inc. · Needle, Assisted Reproduction9 reports
- Cook G55253William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION6 reports
- Cook G55477William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION4 reports
- Cook G38432William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION2 reports
- Cook G55788William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION2 reports
- Cook G55797William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.