Cook G09269Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002092693), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2017Occlusion Within Device; Occlusion Within Device

  THE CUSTOMER REPORTED THAT THE TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER WOULD NOT FLUSH WITH FLUID. ANOTHER CATHETER WAS OPENED TO COMPLETE THE PROCEDURE, WITH NO FURTHER PRODUCT ISSUES REPORTED. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE NECESSITATED AND NO PATIENT ADVERSE EVENTS OCCURRED DUE TO THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE PROVIDED BY THE REPORTER. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976256 ↗