Fuhrman G55713Recalls & 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
- 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 00827002557130), received between May 25, 2016 and Nov 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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
- Manufacturing, Packaging or Shipping Problem1
- Material Separation1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2023Obstruction of Flow; Manufacturing, Packaging or Shipping Problem; Obstruction of Flow; Manufacturing, Packaging or Shipping Problem
DURING PREPARATION FOR A CASE, THE PHYSICIAN DISCOVERED THAT THE COOK FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE CATHETER WAS UNABLE TO BE FLUSHED. IT WAS REPORTED THAT ONLY THE FIRST SIDE HOLE WAS FUNCTIONAL. THE PHYSICIAN ATTEMPTED TO FLUSH THE DEVICE SEVERAL TIMES. EVENTUALLY THE SIDE HOLES BARELY OPENED. THIS PROBLEM WAS DETECTED IN THREE SEPARATE COOK FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE CATHETERS. THE DEVICES WERE NOT USED AND DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18120795 ↗MalfunctionMay 25, 2016Material Separation; Material Separation
THE PLEURAL DRAIN WAS OPENED FOR A PROCEDURE AND THE DRAIN WAS INSERTED INTO THE PATIENT. ON REMOVAL OF THE WIRE, RESISTANCE WAS FELT IN TWO SECTIONS. THE WIRE WAS REMOVED AND NOTED TO BE MISSING THE GREEN COATING IN TWO 1CM SECTIONS, WHICH COULD HAVE BEEN THE CAUSE OF THE RESISTANCE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR REQUIRE ANY ADDITIONAL PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5678129 ↗
Other CATHETER, IRRIGATION devices
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- 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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