Cook G27048Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00827002270480), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT A STUDY PROCEDURE ((B)(6)) TO PLACE A COOK ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER ON (B)(6) 2021 FOR "OTHER DRAINAGE" AND THE DEVICE WAS BEING USED AS A NEPHROURETERAL STENT. DILATION WAS PERFORMED PRIOR TO CATHETER INSERTION, THEN THE CATHETER WAS PLACED USING ULTRASOUND AND FLUOROSCOPY FOR VISUAL GUIDANCE. ON (B)(6) 2021 IT WAS DISCOVERED THAT THE DRAINAGE CATHETER HAD RETRACTED OUTSIDE THE KIDNEY. COMPLETE FLUID EVACUATION WAS NOT ABLE TO BE ACHIEVED USING THIS DEVICE. THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2021. NO ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT'S EXIT FROM THE STUDY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14959439 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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