Cook G07774Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002077744), received between Aug 15, 2017 and Sep 18, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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 18, 2026.
Most reported problems
Device problems
- Failure to Cut1
- Obstruction of Flow1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2019Obstruction of Flow; Obstruction of Flow
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE DEVICE WAS REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE IN WHICH IT WAS IMPLANTED BECAUSE IT IMMEDIATELY BECAME OCCLUDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9081693 ↗MalfunctionAug 15, 2017Failure to Cut
IT WAS REPORTED THAT PRIOR TO USE IT APPEARED THAT THE STYLET SLICED THE END TIP OF THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6793873 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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