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Cook G27043Recalls & reported problems

Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002270435), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjuryDec 15, 2016Material Separation; Material Separation

    IT WAS REPORTED THE PHYSICIAN WANTED TO CHANGE THE DRAINAGE AND OPENED THE MACKLOCK FIXATION AS IT MEANT TO BE THEN STRAIGHTENED OUT THE DRAINAGE WITH A WIRE. UPON COMPLETION AFTER PULLING OUT THE DRAINAGE THE THREAD WAS GONE AND STILL IN THE PATIENT. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY: THE THREAD FROM THE MACLOCK IS STILL IN THE BODY OF THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6178739 ↗

Other CATHETER, NEPHROSTOMY devices

All CATHETER, NEPHROSTOMY devices →

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