Cook G06483Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002064836), received between May 3, 2022 and Mar 22, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Difficult to Remove1
Patient problems
- Failure of Implant2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Difficult to Remove; Difficult to Remove
WHEN IT WAS DISCOVERED THAT THE CATHETER WAS UNABLE TO BE ADVANCED DUE TO THE CATHETER STICKING TO THE CATHETER, IT REQUIRED ANOTHER PUNCTURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18961927 ↗MalfunctionMay 4, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED A PATIENT REQUIRED AN ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER FOR A NEPHROSTOMY. TWO DAYS AFTER PLACEMENT, THE OPERATOR NOTED THE HUB SEPARATED FROM THE CATHETER AND THE DRAINAGE BAG COULD NOT BE CONNECTED. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Failure of Implant
MAUDE report 14279846 ↗InjuryMay 3, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED A PATIENT REQUIRED AN ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER FOR A NEPHROSTOMY. THREE DAYS AFTER PLACEMENT, THE OPERATOR NOTED THE HUB SEPARATED FROM THE CATHETER AND THE DRAINAGE BAG COULD NOT BE CONNECTED. THE CATHETER WAS THEN REPLACED WITH A NEW SIMILAR DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Failure of Implant
MAUDE report 14270281 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.