Cook G55253Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002552531), received between Jul 24, 2023 and Oct 10, 2023 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) HOSPITAL HAD AN ISSUE WITH 7 PATIENTS EXPERIENCING BLEEDING POST OVUM ASPIRATION WITH PRODUCT (FROM SAME LOT NUMBER). ALL SEVEN PATIENTS RECOVERED, A FEW REQUIRED STITCHES, SILVER NITRATE, AND EXTRA DAY IN HOSPITAL FOR OBSERVATIONS.

  Patient problems: Intra-Abdominal Hemorrhage

  MAUDE report 17905284 ↗
• InjuryOct 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) HOSPITAL HAD AN ISSUE WITH 7 PATIENTS EXPERIENCING BLEEDING POST OVUM ASPIRATION WITH PRODUCT (FROM SAME LOT NUMBER). ALL SEVEN PATIENTS RECOVERED, A FEW REQUIRED STITCHES, SILVER NITRATE, AND EXTRA DAY IN HOSPITAL FOR OBSERVATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intra-Abdominal Hemorrhage

  MAUDE report 17892732 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NEEDLE CAUSED TOO MUCH BLEEDING; TOO SHARP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17442568 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NEEDLE CAUSED TOO MUCH BLEEDING; TOO SHARP. THE USER FACILITY NO LONGER WANTS TO USE THIS PRODUCT AND WILL BE RETURNING THEIR REMAINING STOCK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17412567 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NEEDLE CAUSED TOO MUCH BLEEDING; TOO SHARP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17386185 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NEEDLE CAUSED TOO MUCH BLEEDING; TOO SHARP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17386118 ↗