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Cook G10047Recalls & reported problems

Cook Incorporated · Ultrathane, Mac-Loc, Biliary Drainage Catheter Set with Neff Percutaneous Access Set · Class 2 · Implant

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 00827002100473), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Disinfection Or Sterilization Issue” (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

  • Device Disinfection Or Sterilization Issue1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionNov 15, 2017Tear, Rip or Hole in Device Packaging; Device Disinfection Or Sterilization Issue

    DURING THE INSPECTION, IT WAS OBSERVED THAT THERE WAS A MALFUNCTION TO THE STERILE DEVICE PACKAGING., THERE WAS A TEAR IN THE FILM PACKAGING.

    Patient problems: No Patient Involvement

    MAUDE report 7034368 ↗

Other CATHETER, BILIARY, SURGICAL devices

All CATHETER, BILIARY, SURGICAL devices →

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