Cook G55797Recalls & reported problems
William A. Cook Australia Pty. Ltd. · Ovum Aspiration Needle, Double Lumen · 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 00827002557970), received between Jul 31, 2022 and Jul 31, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Collapse” (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
- Adverse Event Without Identified Device or Use Problem1
- Collapse1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2022Collapse; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NEEDLE COLLAPSED 3 FOLLICLES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15136903 ↗
Other NEEDLE, ASSISTED REPRODUCTION devices
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- Cook G55253William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION6 reports
- Cook G55493William A. Cook Australia Pty. Ltd. · NEEDLE, ASSISTED REPRODUCTION4 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.