Fuhrman G55723Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002557239), received between Jul 18, 2016 and Jun 24, 2025 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 1, 2021Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  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 11914623 ↗
• MalfunctionApr 26, 2021Device 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 11723513 ↗
• MalfunctionFeb 25, 2021Device 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 Patient Involvement

  MAUDE report 11379625 ↗
• MalfunctionFeb 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE WIRE OF A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET "SHEARED" AS IT WAS PULLED OUT OF THE CATHETER. THE DEVICE WAS BEING USED AS A "THORACOSTOMY TUBE" FOR A PNEUMOTHORAX. THE (B)(6) MALE PATIENT WAS ORIGINALLY ADMITTED FOR AN ORTHOPEDIC SURGICAL PROCEDURE AND HAD A MUSCULAR BUILD WITH NO CONFOUNDING ANATOMICAL ABNORMALITIES. NO DIFFICULTY WAS EXPERIENCED WHILE INSERTING THE WIRE. AFTER THE SHEARING OF THE WIRE, THE USE OF THE COMPLAINT DEVICE WAS ABORTED BUT THE REST OF THE PROCEDURE WAS COMPLETED WITH A NEW KIT PER THE "USUAL ROUTINE - BEDSIDE, STERILE PRECAUTIONS, UNDER LOCAL ANESTHESIA AND IV NARCOTICS, SELDINGER TECHNIQUE". THIS REPORTEDLY CAUSED MORE PAIN TO THE PATIENT BUT NO ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11308864 ↗
• MalfunctionJul 24, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8821695 ↗
• MalfunctionMar 27, 2018Bent; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE USER FELT RESISTANCE WHEN USING THE FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET, SO SHE REMOVED THE GUIDEWIRE AND FOUND THAT IT WAS BENT. IT WAS NOTED THAT THE PATIENT WAS A PRETERM INFANT. IN ADDITION, SHE FOUND THAT THE WIRE HAD A BREAK IN THE COIL, WITH PART OF THE WIRE MATERIAL PROTRUDING OUTWARD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7373373 ↗
• MalfunctionDec 27, 2016Break; Break

  IT WAS REPORTED THAT DURING A CHEST TUBE PLACEMENT PROCEDURE, THE GUIDE WIRE BROKE WHILE TRYING TO REMOVE FROM PIGTAIL. A NEW KIT WAS OPENED AND THE PROCEDURE HAD TO BE STARTED OVER FROM THE BEGINNING. NO HARM TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6206225 ↗
• InjuryNov 29, 2016Break; Material Separation; Break; Material Separation

  INFORMATION WAS PROVIDED THAT DURING INSERTION OF THE CHEST TUBE IN A 2 POUND NEONATE, THE TIP OF THE TUBE SHEARED OR BROKE IN THE PATIENT'S CHEST. DUE TO THIS EVENT, THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY FOR THORACIC SURGICAL INTERVENTION TO REMOVE THE RETAINED PIECE FROM THE PATIENT'S PLEURAL SPACE. INFORMATION REGARDING PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6133088 ↗
• MalfunctionJul 21, 2016Loose or Intermittent Connection; Difficult to Remove; Unraveled Material; Loose or Intermittent Connection; Difficult to Remove; Unraveled Material

  DURING A DRAINAGE PROCEDURE ON THE FEMALE PATIENT, IT WAS REPORTED THAT THE USER FIRST PUNCTURED WITH THE NEEDLE AND ENTERED WIRE GUIDE THROUGH THE NEEDLE. THEY THEN DILATED AND ENTERED THE DRAIN. HOWEVER, WHEN THEY WANTED TO RETRIEVE THE WIRE IT WAS STUCK. THE USER HAD TO PULL AND HEARD A "KNICK" AND THE WIRE LOOSENED. INFORMATION WAS PROVIDED THAT THE WIRE WAS TATTERED AND THE DRAIN CAME LOOSE FROM THE CONNECTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5811828 ↗
• MalfunctionJul 19, 2016Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use; Material Integrity Problem

  THE INITIAL REPORT STATED THAT THERE WAS A PROBLEM WITH THE COATING. ADDITIONAL INFORMATION PROVIDED BY THE REP STATED THAT DURING INSPECTION OF THE PRODUCT, BEFORE THE PROCEDURE AND PRIOR TO PATIENT CONTACT, THE PHYSICIAN NOTICED THAT SOME PARTS OF THE COATING OF THE WIRE GUIDE WERE REMOVED AND DAMAGED. IT WAS STATED THAT THE PHYSICIAN HURT HERSELF WHEN TOUCHING THE WIRE, SO IT WAS DECIDED NOT TO USE THE PRODUCT ON THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 5804993 ↗
• InjuryJul 18, 2016Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DOCTOR NOTICED WHEN INSPECTING THE PRODUCT THAT SOME PARTS OF THE COATING OF THE WIRE GUIDE WHERE REMOVED AND DAMAGED. IT WAS FURTHER REPORTED THAT THE DOCTOR HURT HERSELF WHEN TOUCHING THE WIRE. THE PRODUCT WAS NOT USED IN THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 5801899 ↗