Cook G38432Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002384323), received between Apr 13, 2023 and Apr 21, 2023 — classified as 2 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NEEDLE WAS PUNCTURING ANTERIOR TO THE BIOPSY LINE. THE ULTRASOUND MANAGER WAS CALLED IN DURING THE PROCEDURE AND BIOPSY LINE WAS TEMPORARILY ADJUSTED TO REPRESENT WHERE THE NEEDLE WAS PUNCTURING. DURING THE FOLLOWING RETRIEVAL ULTRASOUND WAS CALLED IN BECAUSE THE BIOPSY LINE HAD TO BE RECALIBRATED BACK TO ITS ORIGINAL POSITION. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT SEVERAL HOURS AFTER THE PROCEDURE TO FIX THE INTERNAL BLEEDING. FOLLOW UP INFORMATION RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16787102 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NEEDLE WAS PUNCTURING ANTERIOR TO THE BIOPSY LINE. THE ULTRASOUND MANAGER WAS CALLED IN DURING THE PROCEDURE AND BIOPSY LINE WAS TEMPORARILY ADJUSTED TO REPRESENT WHERE THE NEEDLE WAS PUNCTURING. DURING THE FOLLOWING RETRIEVAL ULTRASOUND WAS CALLED IN BECAUSE THE BIOPSY LINE HAD TO BE RECALIBRATED BACK TO ITS ORIGINAL POSITION. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT SEVERAL HOURS AFTER THE PROCEDURE TO FIX THE INTERNAL BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16739373 ↗