FuhrmanRecalls & reported problems across all models
Cook Incorporated · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 8 models of Fuhrman by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between May 11, 2016 and Jun 24, 2025 — classified as 10 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Material Separation” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Fuhrman problems
Device problems
- Material Separation8
- Unraveled Material7
- Break5
- Device Contaminated During Manufacture or Shipping4
- Obstruction of Flow4
- Device Damaged Prior to Use3
- Material Protrusion/Extrusion3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient6
- No Code Available5
- No Patient Involvement3
- Insufficient Information2
- Thrombosis/Thrombus2
- Foreign Body In Patient1
Fuhrman models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fuhrman G55723CATHETER, IRRIGATION16 reports
- Fuhrman G55714CATHETER, IRRIGATION7 reports
- Fuhrman G55715CATHETER, IRRIGATION7 reports
- Fuhrman G55724CATHETER, IRRIGATION3 reports
- Fuhrman G03974CATHETER, IRRIGATION2 reports
- Fuhrman G55713CATHETER, IRRIGATION2 reports
- Fuhrman G55716CATHETER, IRRIGATION1 report
- Fuhrman G55722CATHETER, IRRIGATION1 report
Recent Fuhrman adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT THE WIRE GUIDE FROM A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET BENT AND UNRAVELED DURING INSERTION OF A CHEST TUBE. THE WIRE WAS THEN DISCARDED, AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information
MAUDE report 22323907 ↗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 ↗MalfunctionFeb 19, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE GUIDEWIRE INCLUDED IN THE FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET WAS DIFFICULT TO INSET THROUGH THE NEEDLE DURING A PIGTAIL INSERTION INTO THE RIGHT LUNG OF 24-YEAR- OLD FEMALE PATIENT. THIS REQUIRED REINSERTION AND AN "EXCESSIVE USE OF CONSUMABLES.". THE USER CONFIRMED THAT A WIRE GUIDE STRAIGHTENER WAS NOT USED DURING THE INSERTION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ONE DEVICE WAS RETURNED TO THE MANUFACTURER ON 21JAN2025 FOR EVALUATION. DURING THE PRELIMINARY DEVICE FAILURE ANALYSIS, IT WAS DISCOVERED THAT THE WIRE HAD UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413345 ↗InjuryOct 21, 2024Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Thrombosis/Thrombus
MAUDE report 20498533 ↗MalfunctionSep 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280626 ↗InjuryMay 3, 2024Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 19242934 ↗MalfunctionJan 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION WAS PROVIDED INDICATING A NEW DEVICE SET WAS OBTAINED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18519458 ↗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 ↗MalfunctionNov 13, 2023Obstruction of Flow; Manufacturing, Packaging or Shipping Problem; Obstruction of Flow; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18120760 ↗MalfunctionAug 2, 2023Difficult to Remove; Unraveled Material; Deformation Due to Compressive Stress; Difficult to Remove; Unraveled Material; Deformation Due to Compressive Stress
IT WAS REPORTED THE WIRE GUIDE OF A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE TRAY UNRAVELED. A CHEST TUBE INSERTION PROCEDURE VIA DIRECT STICK WAS PERFORMED ON A PREMATURE 1 DAY-OLD, MALE PATIENT, WHO HAD PNEUMOTHORAX AND IS CURRENTLY IN THE HOSPITAL. AFTER THE PIGTAIL OF THE CATHETER WAS SECURED IN THE CHEST WALL, THE NICU NURSE PRACTITIONER ATTEMPTED TO REMOVE THE WIRE GUIDE. DURING THE REMOVAL, THE WIRE GUIDE STARTED TO UNRAVEL AND COME APART. THE ENTIRE DEVICE WAS REMOVED AND REPLACED IMMEDIATELY WITH ANOTHER CHEST TUBE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17443859 ↗InjuryJun 1, 2023Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion
PER ADDITIONAL INFORMATION PROVIDED ON 08JUN2023, THE CUSTOMER REPORTED THE PATIENT "HAD A ROUGH NIGHT" TO MEAN THE PATIENT EXPERIENCED RESPIRATORY FAILURE IN WHICH THERE WAS SIGNIFICANT REFRACTORY HYPOXIA AND HYPERCARBIA WITH SATURATION BELOW 40 FOR AT LEAST 30 MINUTES CONTINUOUSLY. IT WAS ALSO NOTED THERE WAS A REFRACTORY AIR LEAK WITH CONTINUOUS MANUAL EVACUATION OF AIR. A NEW CHEST TUBE WAS PLACED AND THE PATIENT EXPERIENCED DRAMATIC STABILIZATION WITH THE INITIATION OF INHALED NITRIC OXIDE. HOWEVER, THE FRACTURED PORTION OF THE DEVICE HAS NOT YET TO BE REMOVED.
Patient problems: Foreign Body In Patient; Hypoxia; Low Oxygen Saturation; Respiratory Failure
MAUDE report 17042337 ↗InjuryAug 22, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ADAPTER OF A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET DISCONNECTED FROM THE DRAIN DURING TREATMENT OF A PNEUMOTHORAX IN A MALE PATIENT. THE PHYSICIAN CONNECTED THE ADAPTER TO A 8.5 FR PIG TAIL CHEST TUBE VALVE. THE PATIENT RETURNED THE NEXT DAY PRESENTING WITH SHORTNESS BREATH. IT WAS THEN DISCOVERED THAT THE PATIENT HAD A LARGE PNEUMOTHORAX. UPON EXAMINATION BY A RESIDENT, THE ADAPTER WAS FOUND TO BE DISCONNECTED FROM THE CHEST DRAIN. IT WAS NOTED THAT THE DRAIN WAS NOT CONNECTED CORRECTLY, AS A VINYL CONNECTING TUBE THAT WAS NEEDED FOR ATTACHMENT OF THE ADAPTER TO THE DRAIN WAS MISSING. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Pneumothorax
MAUDE report 15265587 ↗InjuryJan 24, 2022Human-Device Interface Problem; Human-Device Interface Problem
DURING THE NEONATAL RESUSCITATION OF THE PATIENT FOR THE TREATMENT OF A RECURRENT PNEUMOTHORAX, THE CARE TEAM NOTED THAT THE THREE WAY STOP COCK ATTACHED TO THE COOK FUHRMAN PLEURAL PNEUMOPERICARDIAL DRAINAGE CATHETER WAS CLOSED. THE THREE WAY STOPCOCK WAS TO BE IN THE OPEN" POSITION. NEEDLE EXSUFFLATION WAS PREFORMED AS A RESULT OF THE THREE WAY STOPCOCK BEING IN THE CLOSED POSITION. THE CARE TEAM AT THE FACILITY NOTED THAT THE THREE WAY STOPCOCK PROVIDED FOR USE IN THE COOK FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET DOES NOT LOOK LIKE THE USUAL 3 WAY TAPS USED BY THE TEAM. THE COOK FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE REMAINS INSERTED IN THE PATIENT'S THORAX..
Patient problems: Respiratory Insufficiency
MAUDE report 13335177 ↗MalfunctionDec 28, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE IN A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET SEPARATED. THE DEVICE WAS REQUIRED BY A (B)(6) MALE FOR PLEURAL DRAINAGE. DURING THE PROCEDURE, AFTER PLACING THE CATHETER, THE USER PULLED ON THE WIRE GUIDE AND DISCOVERED IT WAS "SPLIT." THE USER THEN OBTAINED ANOTHER DEVICE OF THE SAME LOT AND AGAIN ATTEMPTED TO PLACE THE CATHETER. DURING REMOVAL OF THE REPLACEMENT WIRE GUIDE, THE WIRE AGAIN BROKE. IN THIS OCCURRENCE, A PORTION OF THE WIRE REMAINED IN THE PATIENT. SUBSEQUENTLY, THE USER WAS ABLE TO REMOVE THE REMNANT OF THE WIRE "BY PULLING THE DRAINAGE." THE PROCEDURE WAS COMPLETED BY OBTAINING A THIRD DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. TWO PHOTOS PROVIDED BY THE CUSTOMER DEPICT AN UNRAVELED WIRE GUIDE AND A SEPARATED WIRE GUIDE. THIS REPORT WILL FOCUS ON THE SECOND WIRE GUIDE SEPARATION. THE BROKEN WIRE GUIDE HAS BEEN REPORTED UNDER PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13101499 ↗MalfunctionDec 28, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE IN A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET UNRAVELED. THE DEVICE WAS REQUIRED BY A (B)(6) MALE FOR PLEURAL DRAINAGE. DURING THE PROCEDURE, AFTER PLACING THE CATHETER, THE USER PULLED ON THE WIRE GUIDE AND DISCOVERED IT WAS "SPLIT." THE USER THEN OBTAINED ANOTHER DEVICE OF THE SAME LOT AND AGAIN ATTEMPTED TO PLACE THE CATHETER. DURING REMOVAL OF THE REPLACEMENT WIRE GUIDE, THE WIRE AGAIN BROKE. IN THIS OCCURRENCE, A PORTION OF THE WIRE REMAINED IN THE PATIENT. SUBSEQUENTLY, THE USER WAS ABLE TO REMOVE THE REMNANT OF THE WIRE "BY PULLING THE DRAINAGE." TWO PHOTOS PROVIDED BY THE CUSTOMER AGAIN DEPICTS AN UNRAVELED WIRE GUIDE AND A SEPARATED WIRE GUIDE. THE PROCEDURE WAS COMPLETED BY OBTAINING A THIRD DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THIS REPORT WILL FOCUS ON THE FIRST BROKEN WIRE GUIDE. THE SECOND WIRE GUIDE SEPARATION HAS BEEN REPORTED UNDER PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13101463 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page