Cook G06484Recalls & 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 00827002064843), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2017Break; Break
CUSTOMER REPORTED THAT A PATIENT STATUS POST THORACENTESIS RECEIVED A ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER AS A CHEST TUBE FOR DRAINAGE OF A LARGE PARA PNEUMONIC PLEURAL EFFUSION. THE IMPLANT DATE IS NOT KNOWN. THE CUSTOMER REPORTED THAT THE NURSE RETURNED TO THE PATIENTS' ROOM AND DISCOVERED THAT THE CHEST TUBE WAS DISCONNECTED. THE NURSE CLAMPED THE TUBE AND FOUND THAT THE TUBE WAS BROKEN OFF AT THE JUNCTION OF THE TUBE AND STOPCOCK. THE PHYSICIAN BELIEVES THIS EVENT MAY BE A MANUFACTURING ISSUE, HOWEVER, THE PATIENTS' NURSE "BELIEVES THIS MAY BE RELATED TO THE PATIENT'S AGITATION AND WITHDRAWAL SYMPTOMS." ADDITIONAL EVENT AND PATIENT INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Code Available
MAUDE report 6721079 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page