Cook G05389Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002053892), received between Jul 28, 2017 and Dec 18, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2018Corroded; Component Missing

  IT WAS REPORTED THAT DURING THE BIOPSY OF LEFT VENTRICLE, THE FLEXIBLE MYOCARDIAL BIOPSY FORCEPS WOULD NOT OPEN INSIDE THE PATIENT WHEN ADVANCED THROUGH THE GUIDING CATHETER. AFTER THE PROCEDURE, THE USER CHECKED IF THE DEVICE SHAFT OF THE DEVICE WAS BENT. IT WAS FURTHER NOTED THAT THE HANDLE WOULD NOT ACTUATE THE FORCEPS DUE TO A MISSING RIVET AND INTERNAL CORROSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173808 ↗
• InjuryAug 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS ALLEGED THAT A PATIENT EXPERIENCED A PERICARDIAL EFFUSION AFTER A PHYSICIAN USED A COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS PRODUCT SET FOR A MYOCARDIAL BIOPSY PROCEDURE. THE COMPLAINANT REPORTED THAT THE USE OF THE COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS WAS SUCCESSFUL AND THE PRODUCT WORKED AS IT SHOULD. HOWEVER, A PUNCTURE TO THE RIGHT V. FEMORALIS WAS REPORTED IN RELATION TO AN "ANGIOKIT." THE PERICARDIAL EFFUSION WAS SUCCESSFULLY STOPPED WITH A TAMPONADE, AND IT HAS NOT BEEN REPORTED THAT THE PATIENT EXPERIENCED ANY FURTHER ADVERSE EVENTS.

  Patient problems: Pericardial Effusion

  MAUDE report 6764953 ↗
• InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS ALLEGED THAT A PATIENT EXPERIENCED A PERICARDIAL EFFUSION AFTER A PHYSICIAN USED A COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS PRODUCT SET FOR A MYOCARDIAL BIOPSY PROCEDURE. THE COMPLAINANT REPORTED THAT THE USE OF THE COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS WAS SUCCESSFUL AND THE PRODUCT WORKED AS IT SHOULD. HOWEVER, A PUNCTURE TO THE RIGHT V. FEMORALIS WAS REPORTED IN RELATION TO AN "ANGIOKIT." THE PERICARDIAL EFFUSION WAS SUCCESSFULLY STOPPED WITH A TAMPONADE, AND IT HAS NOT BEEN REPORTED THAT THE PATIENT EXPERIENCED ANY FURTHER ADVERSE EVENTS.

  Patient problems: Pericardial Effusion

  MAUDE report 6752306 ↗