PLEUR-EVAC IPN028442Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 34026704631231), received between Feb 10, 2021 and Sep 8, 2025 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Material Puncture/Hole; Gas/Air Leak

  AIR LEAK THROUGH PLEUR-EVAC WHEN ON SUCTION DID NOT RESOLVE WITH REINFORCING DRESSING AROUND CHEST TUBE. CHANGING PLEUR-EVAC RESOLVED THE AIR LEAK, SUGGESTING THE CHAMBER OR TUBING MAY HAVE A HOLE. POSTOPERATIVE EFFUSION, WHICH WAS DRAINING WELL PRIOR TO MORNING OF [DATE REDACTED], STOPPED DRAINING WELL DURING THIS PERIOD OF TIME.

  Patient problems: Pericardial Effusion

  MAUDE report 22991971 ↗
• MalfunctionJul 28, 2023

  PATIENT WAS PLACED ON A PLEUR-EVAC FOLLOWING OPEN HEART SURGERY. IN THE SURGICAL ICU, IT WAS NOTED THAT THE PLEUR-EVAC FAILED AS IT WOULD NOT KEEP SUCTION. THE PLEUR-EVAC WAS CHANGED, WHICH RESOLVED THE AIR LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412846 ↗
• MalfunctionMay 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT WHO WAS ADMITTED WITH A SPONTANEOUS PNEUMOTHORAX, THE PLEUREVAC "WAS UNABLE TO MAINTAIN WATER LEVEL AT 0 DESPITE USING PRESSURE RELEASE AND/OR ADDING SALINE". THE PLEUREVAC WAS FIRST STARTED WITH THE SUCTION ON AND THEN WAS TRANSITIONED TO GRAVITY. THE REPORT STATES "THE WATER LEVEL WAS VERY LOW, BELOW -2 SO WE ADDED FLUID THEN THE PRESSURE SHOT WAY UP THE CHAMBER AND WE COULDN'T RELIEVE IT EVEN WITH PRESSURE VALVE RELEASED". AS A RESULT, THE PLEUREVAC WAS REMOVED AND A 2ND PLEUREVAC WAS USED. FURTHER INFORMATION STATES "THE MALFUNCTION OF THE UNIT DID NOT AFFECT THE PATIENT AND HE HAS SINCE BEEN TRANSFERRED TO ANOTHER SITE FOR SPECIALIST CARE. NOT RELATED TO CHEST DRAINAGE SYSTEM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954426 ↗
• MalfunctionApr 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE "INCIDENT OCCURRED IN THE RESUSCITATION DEPARTMENT. THERE WAS A PLEURAL LIQUID LEAK AT THE LEVEL OF THE RED CONNECTOR. THERE WAS NO CONSEQUENCE FOR THE PATIENT". NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799790 ↗
• MalfunctionApr 14, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: DEFECTIVE DRAINAGE SYSTEM WITH BUBBLING WHEN IT SHOULD NOT. THE AIR LEAK WAS FOUND AT THE RE/BLUE CONNECTION. THE DEVICE WAS CHANGED. NO CLINICAL CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED ON 14 APRIL 2023 STATES THAT THE PATIENT'S CONDITION DID NOT WORSEN AFTER THE EVENT, THERE WAS NO INJURY TO THE PATIENT, AND THAT THERE WAS NO MEDICAL INTERVENTION. THE LEAK OCCURRED WHILE TRANSPORTING THE PATIENT BACK FROM SURGERY AND IT WAS AN AIR LEAK THAT OCCURRED ON THE RED/BLUE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743849 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED ISSUE: BLOOD LEAKAGE WAS DETECTED THROUGH THE RED/BLUE CONNECTION OF THE TUBING. THE SYSTEM WAS CHANGED AND THE ISSUE WAS RESOLVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622377 ↗
• MalfunctionMar 27, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: BLOOD LEAKAGE WAS DETECTED THROUGH THE RED/BLUE CONNECTION OF THE TUBING. THE SYSTEM WAS CHANGED AND THE ISSUE WAS RESOLVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622348 ↗
• MalfunctionFeb 23, 2023Leak/Splash; Leak/Splash

  REPORTED ISSUE: WE OBSERVED A LEAK ON THE SECTION OF THE TUBE BETWEEN THE CHAMBER AND THE RED CONNECTOR. THE DEVICE WAS REPLACED AND THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431002 ↗
• MalfunctionDec 26, 2022Defective Component; Defective Component

  REPORTED ISSUE: UPON CONNECTING THE PLEUR-EVAC SYSTEM TO THE CATHETER, DRAINAGE FLOWED. IT WAS NOTED THAT A LARGE LEAK WAS OCCURRING FROM THE BONDED CONNECTION BETWEEN THE SILICONE DRAINAGE TUBING AND RED CONNECTOR PORT OR BETWEEN THE RED CONNECTOR PORT AND BLUE CONNECTOR. THE FEMALE PATIENT HAD CORONARY BYPASS SURGERY AND THE CHEST DRAIN WAS CONNECTED AT THE END OF PROCEDURE; THE FLOATER WAS NOT SHOWING WHEN CONNECTED TO THE SUCTION AND NO DRAINAGE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048421 ↗
• MalfunctionDec 26, 2022Leak/Splash; Defective Component; Leak/Splash; Defective Component

  REPORTED ISSUE: UPON CONNECTING THE PLEUR-EVAC SYSTEM TO THE CATHETER, DRAINAGE FLOWED. IT WAS NOTED THAT A LARGE LEAK WAS OCCURRING FROM THE BONDED CONNECTION BETWEEN THE SILICONE DRAINAGE TUBING AND RED CONNECTOR PORT OR BETWEEN THE RED CONNECTOR PORT AND BLUE CONNECTOR. THE FEMALE PATIENT HAD CORONARY BYPASS SURGERY AND THE CHEST DRAIN WAS CONNECTED AT THE END OF PROCEDURE; THE FLOATER WAS NOT SHOWING WHEN CONNECTED TO THE SUCTION AND NO DRAINAGE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048417 ↗
• MalfunctionNov 17, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE FLOATER WAS NOT SHOWING WHEN ATTACHED TO SUCTION. THE DEVICE WAS BEING USED FOR A CORONARY BYPASS AND A NEW UNIT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814487 ↗
• MalfunctionOct 17, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT UPON ARRIVAL THE PATIENT WAS SHOWING AN AIR LEAK. THE MD TESTED VARIOUS POINTS IN THE LINES AND SYSTEM. IT WAS DETERMINED THAT THE BLUE CONNECTOR CLOSEST TO THE PLEUR-EVAC BOX WAS MALFUNCTIONING. A NEW PLEUR-EVAC BOX WAS EXCHANGED FOR THE ORIGINAL AND THE AIR LEAK WAS NO LONGER PRESENT.

  Patient problems: Insufficient Information

  MAUDE report 15619122 ↗
• MalfunctionSep 27, 2022Leak/Splash; Leak/Splash

  WHEN THE PATIENT WAS REASSESSED LATER IN THE NIGHT, BOTH NURSING AND PATIENT COULD HEAR WHISTLING THAT SOUNDED LIKE A LEAK FROM THE TUBE. THE CONNECTION SITE WAS CHECKED BETWEEN THE PLEUR-EVAC AND TUBE, THE CHEST TUBE SITE WAS CHECKED AT THE CHEST AND WERE BOTH FINE. LEAK COULD STILL BE HEARD. THE ENTIRE PLEUR-EVAC SYSTEM WAS CHANGED, THE WHISTLING SOUND THEN STOPPED, AND THE AIR LEAK ALSO STOPPED. THERE MUST HAVE BEEN A HOLE SOMEWHERE IN THE PLEUR-EVAC TUBING. OVERNIGHT, LEFT CHEST TUBE PLACED TO -40CMH20 AND RIGHT SIDE PLACED TO -20CMH20 ,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494763 ↗
• MalfunctionSep 13, 2022Gas/Air Leak; Gas/Air Leak

  3 UNITS OF SAME LOT NUMBER WERE SHOWING EXCESSIVE AIR BUBBLING, WHILST PATIENTS WERE IN ICU. TUBING WAS CLAMPED ABOVE RED/BLUE CONNECTOR AND BUBBLING STILL OCCURRED. DRAINS WERE SWAPPED WITH NEW UNITS AND CHANGED VIA THE RED/BLUE CONNECTOR AND BUBBLING STOPPED INDICATING ISSUE WITH THE RED/BLUE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411810 ↗
• MalfunctionSep 13, 2022Gas/Air Leak; Gas/Air Leak

  3 UNITS OF SAME LOT NUMBER WERE SHOWING EXCESSIVE AIR BUBBLING, WHILST PATIENTS WERE IN ICU. TUBING WAS CLAMPED ABOVE RED/BLUE CONNECTOR AND BUBBLING STILL OCCURRED. DRAINS WERE SWAPPED WITH NEW UNITS AND CHANGED VIA THE RED/BLUE CONNECTOR AND BUBBLING STOPPED INDICATING ISSUE WITH THE RED/BLUE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411800 ↗
• MalfunctionSep 13, 2022Gas/Air Leak; Gas/Air Leak

  3 UNITS OF SAME LOT NUMBER WERE SHOWING EXCESSIVE AIR BUBBLING, WHILST PATIENTS WERE IN ICU. TUBING WAS CLAMPED ABOVE RED/BLUE CONNECTOR AND BUBBLING STILL OCCURRED. DRAINS WERE SWAPPED WITH NEW UNITS AND CHANGED VIA THE RED/BLUE CONNECTOR AND BUBBLING STOPPED INDICATING ISSUE WITH THE RED/BLUE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411722 ↗
• MalfunctionSep 6, 2022Leak/Splash; Leak/Splash

  CUSTOMER REPORTED THAT BLOOD IS LEAKING OUT OF THE QUICK DISCONNECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363187 ↗
• MalfunctionAug 2, 2022Break; Break

  DURING THE DECORTICATION + PLEURECTOMY PROCEDURE, THORACIC DRAINAGE, PLEUR-EVAC, IS PLACED AND CONNECTED TO THE PATIENT'S TUBE, AT WHICH TIME IT IS IDENTIFIED THAT THE HOSE IS BROKEN IN THE RED CONNECTION , THE CONNECTION CLOSEST TO THE PLEUR-EVAC. THE DEVICE IS CHANGED AND ATTENTION IS CONTINUED WITH SUCTION WITHOUT PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 15146848 ↗
• MalfunctionAug 1, 2022Leak/Splash; Leak/Splash

  INCIDENT HAPPENED IN THE RESUSCITATION DEPARTMENT. ON (B)(6) 2022. INVOLVED A FEMALE PATIENT. WE OBSERVED ON THE X-RAY THAT THERE WAS A DISCREPANCY BETWEEN THE PATIENT WHOSE PNEUMOTHORAX WAS SOLVED WITH SUCCESS AND THE PLEUR-EVAC THAT WAS STILL BUBBLING. WE BELIEVE THERE IS A LEAK AT THE LEVEL OF THE TUBING BETWEEN THE BLUE ATS CONNECTOR AND THE WATER FILLED SUCTION COLUMN. THE CONSEQUENCE WAS A DELAY IN THE DEPARTMENT. WE STILL CHANGED THE PLEUR-EVAC AND THE NEW PLEUR-EVAC WAS NOT BUBBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139037 ↗
• MalfunctionJun 13, 2022Leak/Splash; Leak/Splash

  LEAKING AT RED/BLUE CONNECTOR ON (B)(4) DIFFERENT DEVICES (PRIOR TO USE ON TWO DIFFERENT PATIENTS. THE LEAK WAS FOUND WHEN INITIALLY CONNECTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674617 ↗
• MalfunctionJun 13, 2022Leak/Splash; Leak/Splash

  LEAKING AT RED/BLUE CONNECTOR ON 2 DIFFERENT DEVICES PRIOR TO USE ON TWO DIFFERENT PATIENTS. THE LEAK WAS FOUND WHEN INITIALLY CONNECTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674473 ↗
• MalfunctionJun 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THERE ARE SOME PUNCTURE HOLES IN THE PLASTIC PACKAGING THAT THE DRAIN COMES IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14647998 ↗
• MalfunctionMar 25, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER EXPLAINED THAT THERE WAS AN ISSUE SURROUNDING AN ONGOING AIR LEAK. THEY BELIEVE THE CAUSE OF THE LEAK IS LARGELY DUE TO A DEFECTIVE RED CONNECTOR ON THE QUICK DISCONNECT. THERE WAS NO PATIENT INJURY BECAUSE THE NP DISCOVERED THE PROBLEM AND DID MULTIPLE TROUBLESHOOTING THINGS TO FIGURE OUT THE ISSUE. THE ISSUE WAS RESOLVED BY UNPLUGGING THE TUBING FROM THE RED CONNECTOR AND RECONNECTING IT WITH SOME FORCE.

  Patient problems: Insufficient Information

  MAUDE report 13912759 ↗
• MalfunctionFeb 28, 2022Improper Flow or Infusion; Suction Failure; Improper Flow or Infusion; Suction Failure

  INCIDENT OCCURRED ON (B)(6) 2022 IN THE RESUSCITATION DEPARTMENT. THE CHEST DRAIN WAS INSERTED AND THEN THE PLEUR EVAC WAS CONNECTED, SUCTION AT 20 CHECKED, ORANGE INDICATOR CHECKED, LIQUID INTRODUCED FOR BUBBLING. ONLY ABOUT 200 ML OF LIQUID WERE REMOVED WHILE THE ULTRASOUND PERFORMED SHOWED A GREATER AMOUNT OF FLUID. THE USER CONNECTED A SYRINGE DIRECTLY TO THE DRAIN AND WAS ABLE TO ASPIRATE APPROXIMATELY 300 ML. WHEN THE SYSTEM WAS DISCONNECTED IT DID SHOW SUCTION BUT NO FLUID WAS COLLECTED. BETWEEN THE USE OF EACH SYRINGE, THE USER RECONNECTED THE PLEUR EVAC BUT HE ASPIRATED NOTHING. ANOTHER PLEUR EVAC WAS THEREFORE PLACED AND APPROXIMATELY 1100 ML WERE ASPIRATED WITH THIS NEW DEVICE. THERE HAVE BEEN NO OTHER INCIDENTS REPORTED. THE USERS ARE EXPERIENCED WITH THE USE OF THIS DEVICE. ADDITIONAL INFORMATION: THE PATIENT DID NOT SUFFER A PNEUMOTHORAX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620946 ↗
• MalfunctionNov 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  INSIDE STERILE WRAPPING OF PLEUR-EVAC A-6000-08LF UNIT HAD A SMALL TEAR. PLASTIC WRAPPING WAS INTACT PER CONTACT EMAIL. PRODUCT UNUSED AND CONTACT WOULD LIKE TO KNOW WHAT TO DO WITH UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853254 ↗