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Tenckhoff G09085Recalls & reported problems

Cook Incorporated · Tenckhoff Acute Peritoneal Dialysis Catheter Set Silicone Catheter With 11Fr Peel-Away Introducer Set · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002090859), received between Dec 16, 2018 and Dec 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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

Device problems

  • Fitting Problem1
  • Fluid/Blood Leak1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 16, 2018Fluid/Blood Leak; Fitting Problem

    IT WAS REPORTED THAT DURING THE PERITONEAL DIALYSIS, A LUER LOCK CONNECTION ON TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER WAS LEAKING WHEN CONNECTED O ANOTHER MANUFACTURER'S DIALYSIS BAG. THE LUER LOCK WAS NOT A "SNUG FIT" WITH THE OTHER MANUFACTURER'S KIT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8167876 ↗

Other CATHETER, PERITONEAL devices

All CATHETER, PERITONEAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.