Cook G08289Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002082892), received between Aug 2, 2016 and Feb 12, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE WIRE GUIDE OF THE PERICARDIOCENTESIS CATHETER SET WAS INSERTED INTO THE PUNCTURE NEEDLE, RESISTANCE WAS MET. THE OPERATOR STOPPED USING THE DEVICE, AND REPLACED IT WITH ANOTHER TO COMPLETE THE PROCEDURE. IT WAS LATER DISCOVERED THAT THE TIP OF THE GUIDEWIRE WAS MISSING FROM THE PRODUCT FOLLOWING USE IN THE PATIENT, AND THE CUSTOMER IS REPORTED THAT THE TIP REMAINED INSIDE THE PATIENT. THE COMPLAINT DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7264887 ↗
• MalfunctionOct 19, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERICARDIOCENTIS DRAINAGE PROCEDURE. DURING THE PROCEDURE, BLOOD LEAKED NEAR THE STOP COCK. THE USER PLACED THE CATHETER AND ATTEMPTED TO ASPIRATE FROM THE THREE-WAY STOP COCK IN ORDER TO START THE DRAINAGE PROCESS. HOWEVER, THIS FAILED BECAUSE OF THE BLOOD LEAKAGE. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6040527 ↗
• MalfunctionAug 2, 2016Crack; Crack

  IT WAS REPORTED THAT A DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S PERICARDIAL TO DRAIN PERICARDIAL FLUID. THE THREE-WAY STOPCOCK WAS CONNECTED BY THE PHYSICIAN, HOWEVER, THE PHYSICIAN COULD NOT ASPIRATE THE FLUID DUE TO A CRACK IN THE THREE WAY STOP COCK. ANOTHER PACKAGE WAS OPENED TO COMPLETE THE PERICARDIAL DRAINAGE TREATMENT. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5839479 ↗