Fuhrman G55716Recalls & reported problems
Cook Incorporated · Fuhrman Pleural/Pneumopericardial Drainage Set · Class 1
All models of Fuhrman (8)
Data updated Oct 16, 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 00827002557161), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
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.
InjuryFeb 24, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ADAPTOR INCLUDED IN THE FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET LEAKED FOLLOWING A PNEUMOTHORAX DRAINAGE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE DEVICE WAS PLACED IN (B)(6) 2025. BUBBLING WAS LATER OBSERVED IN THE PLEURAL DRAIN AND LEAKAGE WAS IDENTIFIED AT THE LUER CONNECTION BETWEEN THE DRAIN ITSELF AND THE BLUE CONICAL FITTING. THE DRAINAGE PERIOD WAS PROLONGED DUE TO THE ASSUMPTION OF A PLEURAL BREACH. ADDITIONALLY, THE PATIENT REQUIRED REPLACEMENT OF THE PLEURAL DRAIN AND ENHANCED CLINICAL MONITORING. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21449044 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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