PLEUR-EVAC IPN028484Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 34026704631668), received between Feb 1, 2021 and Feb 27, 2023 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (26 reports).

1 other recall cover devices cleared under the same FDA submission (K962856); they may or may not involve this specific model.

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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  REPORTED ISSUE: AN AIR LEAK WAS DETECTED. THE BLUE CONNECTOR SEEMED LOOSE WHEN CONNECTED TO TUBING COMING FROM THE PATIENT. SWITCHED OUT FOR ANOTHER UNIT USING SAME TUBING COMING FROM PATIENT AND AIR LEAK WENT AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16447870 ↗
• MalfunctionDec 30, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  REPORTED ISSUE: INCIDENT OCCURRED ON (B)(6) 2022 IN THE PNEUMO- IMMUNO ALLERGOLOGY DEPARTMENT. A PLEUR-EVAC DRAIN WAS INSERTED IN A PATIENT SUFFERING FROM A PLEURAL EFFUSION. WHEN UNCLAMPING THE TUBING, PLEURAL FLUID WENT INTO THE DEVICE, THE DOCTOR FOUND A LEAK, AND OBSERVED A CRACK IN THE TUBING AT THE LEVEL OF THE CLAMP. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS IS AN ISOLATED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077738 ↗
• MalfunctionNov 9, 2022Leak/Splash; Leak/Splash

  REPORTED ISSUE: THE BUBBLES IN THE COLUMNS ARE INCREASED WHICH REPRESENTS FOR US A PULMONARY A/D LEAK TOO DIFFICULT TO EVALUATE, EXA GGERATED DOUBTFUL BUBBLES WHICH DO NOT ALWAYS REFLECT REALITY WHICH INCREASES AVERAGE DURATION OF STAY. ADDITIONAL INFORMATION INDICATES THAT DRIED BLOOD ACCUMULATED AT THE RED/BLUE CONNECTION AND THERE WAS CONTINUOUS BUBBLING. THE PLEUR-EVAC WAS CHANGED. THE DRAIN WAS CLAMPED FOR 24 HOURS AND THE CHEST X-RAY SHOWS NO SUBCUTANEOUS EMPHYSEMA AND NO PULMONARY AVULSION, THE DRAIN WAS REMOVED AND THE PATIENT IS OK. THE ASPIRATION SOURCE WAS SET AT 80KPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760326 ↗
• MalfunctionApr 14, 2022Air/Gas in Device

  PLEUROVACS HAVE BEEN NOTED TO HAVE BUBBLING IN CHAMBER. THE SYSTEM WAS EXCHANGED FOR A NEW PLEUROVAC AND THERE WAS RESOLUTION OF THE ISSUE, RULING OUT INAPPROPRIATE SEAL ON PATIENTS.

  Patient problems: Insufficient Information

  MAUDE report 14110749 ↗
• MalfunctionNov 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS A LEAK IN THE TUBING OF THE CIRCUIT THAT COMES OUT OF THE PLEUREVAC WHICH WE DO NOT TOUCH (IT'S WRAPPED AND THE ONLY MANIPULATION WE DO IS TO CONNECT THE END OF THIS TUBING WITH THE DRAIN) AND WHICH SHOULD BE TOTALLY SEALED. TRIED TO TIGHTEN IT AGAIN BUT THE DRAINED LIQUID WAS STILL LEAKING OUT OF THE TUBING. ADDITIONAL INFORMATION INDICATES THE LEAK OF PLEURAL FLUID OCCURRED AT THE RED/BLUE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796897 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN THE EMERGENCY DEPARTMENT AND THE PULMONOLOGY PLANT OF THE SAN PEDRO HOSPITAL IT HAS BEEN DETECTED 6 TIMES ON 6 DIFFERENT PATIENTS SINCE (B)(6) 2021 THAT THE CONNECTION OF THE TUBE WITH THE PLEUR-EVAC RUBBER IS NOT WATERTIGHT LEADING TO THE LEAKS IN THE CHAMBER AND EVENT EXIT OF PLEURAL FLUID TROUGH THE CONNECTION. THIS HAS GENERATED ERRORS IN THE DIAGNOSIS OF THE EVOLUTION OF THE PATIENT'S PULMONARY PATHOLOGY (DETECTING A NON-REAL-LEAK) AND CAUSING LATE WITHDRAWAL OF THE THORACIC TUBE, INCREASING THE DAYS OF HOSPITALIZATION, IN ADDITION TO A POSSIBLE RISK OF INFECTION SINCE NOT BEING PROPERLY SEALED IS A GATEWAY TO MICROORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507815 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN THE EMERGENCY DEPARTMENT AND THE PULMONOLOGY PLANT OF (B)(6) HOSPITAL IT HAS BEEN DETECTED 6 TIMES ON 6 DIFFERENT PATIENTS SINCE AUGUST 2021 THAT THE CONNECTION OF THE TUBE WITH THE PLEUR-EVAC RUBBER IS NOT WATERTIGHT LEADING TO THE LEAKS IN THE CHAMBER AND EVENT EXIT OF PLEURAL FLUID TROUGH THE CONNECTION. THIS HAS GENERATED ERRORS IN THE DIAGNOSIS OF THE EVOLUTION OF THE PATIENT'S PULMONARY PATHOLOGY (DETECTING A NON-REAL-LEAK) AND CAUSING LATE WITHDRAWAL OF THE THORACIC TUBE, INCREASING THE DAYS OF HOSPITALIZATION, IN ADDITION TO A POSSIBLE RISK OF INFECTION SINCE NOT BEING PROPERLY SEALED IS A GATEWAY TO MICROORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507751 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN THE EMERGENCY DEPARTMENT AND (B)(6) HOSPITAL IT HAS BEEN DETECTED 6 TIMES ON 6 DIFFERENT PATIENTS SINCE (B)(6) 2021 THAT THE CONNECTION OF THE TUBE WITH THE PLEUR-EVAC RUBBER IS NOT WATERTIGHT LEADING TO THE LEAKS IN THE CHAMBER AND EVENT EXIT OF PLEURAL FLUID TROUGH THE CONNECTION. THIS HAS GENERATED ERRORS IN THE DIAGNOSIS OF THE EVOLUTION OF THE PATIENT'S PULMONARY PATHOLOGY (DETECTING A NON-REAL-LEAK) AND CAUSING LATE WITHDRAWAL OF THE THORACIC TUBE, INCREASING THE DAYS OF HOSPITALIZATION, IN ADDITION TO A POSSIBLE RISK OF INFECTION SINCE NOT BEING PROPERLY SEALED IS A GATEWAY TO MICROORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507704 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN THE EMERGENCY DEPARTMENT AND THE PULMONOLOGY PLANT OF THE (B)(6) HOSPITAL IT HAS BEEN DETECTED 6 TIMES ON 6 DIFFERENT PATIENTS SINCE (B)(6) 2021 THAT THE CONNECTION OF THE TUBE WITH THE PLEUR-EVAC RUBBER IS NOT WATERTIGHT LEADING TO THE LEAKS IN THE CHAMBER AND EVENT EXIT OF PLEURAL FLUID TROUGH THE CONNECTION. THIS HAS GENERATED ERRORS IN THE DIAGNOSIS OF THE EVOLUTION OF THE PATIENT'S PULMONARY PATHOLOGY (DETECTING A NON-REAL-LEAK) AND CAUSING LATE WITHDRAWAL OF THE THORACIC TUBE, INCREASING THE DAYS OF HOSPITALIZATION, IN ADDITION TO A POSSIBLE RISK OF INFECTION SINCE NOT BEING PROPERLY SEALED IS A GATEWAY TO MICROORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507678 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN THE EMERGENCY DEPARTMENT AND THE PULMONOLOGY PLANT OF THE SAN PEDRO HOSPITAL IT HAS BEEN DETECTED 6 TIMES ON 6 DIFFERENT PATIENTS SINCE (B)(6) 2021 THAT THE CONNECTION OF THE TUBE WITH THE PLEUR-EVAC RUBBER IS NOT WATERTIGHT LEADING TO THE LEAKS IN THE CHAMBER AND EVENT EXIT OF PLEURAL FLUID TROUGH THE CONNECTION. THIS HAS GENERATED ERRORS IN THE DIAGNOSIS OF THE EVOLUTION OF THE PATIENT'S PULMONARY PATHOLOGY (DETECTING A NON-REAL-LEAK) AND CAUSING LATE WITHDRAWAL OF THE THORACIC TUBE, INCREASING THE DAYS OF HOSPITALIZATION, IN ADDITION TO A POSSIBLE RISK OF INFECTION SINCE NOT BEING PROPERLY SEALED IS A GATEWAY TO MICROORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507647 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN THE EMERGENCY DEPARTMENT AND THE PULMONOLOGY PLANT OF THE SAN PEDRO HOSPITAL IT HAS BEEN DETECTED 6 TIMES ON 6 DIFFERENT PATIENTS SINCE (B)(6) 2021 THAT THE CONNECTION OF THE TUBE WITH THE PLEUR-EVAC RUBBER IS NOT WATERTIGHT LEADING TO THE LEAKS IN THE CHAMBER AND EVENT EXIT OF PLEURAL FLUID TROUGH THE CONNECTION. THIS HAS GENERATED ERRORS IN THE DIAGNOSIS OF THE EVOLUTION OF THE PATIENT'S PULMONARY PATHOLOGY (DETECTING A NON-REAL-LEAK) AND CAUSING LATE WITHDRAWAL OF THE THORACIC TUBE, INCREASING THE DAYS OF HOSPITALIZATION, IN ADDITION TO A POSSIBLE RISK OF INFECTION SINCE NOT BEING PROPERLY SEALED IS A GATEWAY TO MICROORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507632 ↗
• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT HAPPENED AT THE THORACIC SURGERY DEPARTMENT. THERE WAS AN ABNORMAL BUBBLING (NOT DUE TO THE PATIENT). THE LEAK WAS AT THE LEVEL OF THE ATS RED AND BLUE CONNECTOR. DESPITE THE CLAMPING THE BUBBLING WAS REMAINING. TO SOLVE THE ISSUE WE CHANGED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585335 ↗
• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS DIRECT AN AIR-LEAK. SWITCH TO OTHER SAHARA WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584865 ↗
• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS DIRECT AN AIR-LEAK WITH NOISE. WHEN PUSHING HARD ON THE CONNECTOR IT IS SOLVED. A NEW SAHARA WITH THE SAME LOT NUMBER WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581062 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS AN AIR-LEAK BUT THEY COULD NOT FIND WHERE. NEW SAHARA WAS OK. THEY USE THE SAHARA WITH SMALL DRAIN NEO 10 FR. BOTH COMPLAINED ISSUES WERE NOTED ON ONE PATIENT. WITH A CLAMP THERE WAS STILL A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547161 ↗
• MalfunctionMar 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS DIRECT AN AIR-LEAK; SWITCHED TO ANOTHER SAHARA WAS OK. ADDITIONAL INFORMATION: PHOTOGRAPH SHOWS LEAK OCCURRED AT THE RED/BLUE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494990 ↗
• MalfunctionMar 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS DIRECT AN AIR-LEAK; SWITCHED TO ANOTHER SAHARA WAS OK. ADDITIONAL INFORMATION: PHOTOGRAPH SHOWS LEAK OCCURRED AT THE RED/BLUE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494937 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS AN AIR LEAK BUT NOT IN THORAX PHOTOGRAPH. AFTER INVESTIGATION WE THINK IT IS IN THE TUBE OF THE SAHARA CONNECTION BLUE RED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408269 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS AN AIR LEAK BUT NOT IN THORAX PHOTOGRAPH. AFTER INVESTIGATION WE THINK IT IS IN THE TUBE OF THE SAHARA CONNECTION BLUE RED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408264 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS AN AIR LEAK BUT NOT IN THORAX PHOTOGRAPH. AFTER INVESTIGATION WE THINK IT IS IN THE TUBE OF THE SAHARA CONNECTION BLUE RED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408243 ↗
• MalfunctionFeb 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS LEAKING AT THE RED AND BLUE CONNECTORS ON THE PLEUR-EVAC TUBING OF BOTH S-1100-08LF. LOT' 74F2001464. IT DID NOT SEEM TO BE WORKING PROPERLY AFTER THE LEAK. AFTER 2 UNITS, THEY FOUND ANOTHER ONE TO PUT ON THE PATIENT. IT WAS LATER REPORTED THAT THEY USED ANOTHER 2 S-1100-08LF CHEST DRAINS LOT'74F2001464, BUT THESE 2 WERE LEAKING ALSO AT THE SAME SITE. THEY HAVE A PICTURE THAT WAS SENT. PICTURE BELOW WAS IN BED 2, WAS DRIPPING BLOOD INTO THE FLOOR ON ARRIVAL. THAT IS WHY A TOWEL IS ON THE FLOOR. THE BOTTOM PICTURE HAD AN AUDIBLE AIR LEAK AT THE RED AND BLUE CONNECTORS. WE TRIED PUSHING THE CONNECTORS TOGETHER, BUT THE LEAK CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372184 ↗
• MalfunctionFeb 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS LEAKING AT THE RED AND BLUE CONNECTORS ON THE PLEUR-EVAC TUBING OF BOTH S-1100-08LF. LOT: 74F2001464. IT DID NOT SEEM TO BE WORKING PROPERLY AFTER THE LEAK. AFTER 2 UNITS, THEY FOUND ANOTHER ONE TO PUT ON THE PATIENT. IT WAS LATER REPORTED THAT THEY USED ANOTHER 2 S-1100-08LF CHEST DRAINS LOT: 74F2001464, BUT THESE 2 WERE LEAKING ALSO AT THE SAME SITE. THEY HAVE A PICTURE THAT WAS SENT. PICTURE BELOW WAS IN BED 2, WAS DRIPPING BLOOD INTO THE FLOOR ON ARRIVAL. THAT IS WHY A TOWEL IS ON THE FLOOR. THE BOTTOM PICTURE HAD AN AUDIBLE AIR LEAK AT THE RED AND BLUE CONNECTORS. WE TRIED PUSHING THE CONNECTORS TOGETHER, BUT THE LEAK CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372176 ↗
• MalfunctionFeb 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT AIR LEAKAGE IN THE RED-BLUE CONNECTION 4 TIMES. THE LOT NUMBER IS NOT AVAILABLE BECAUSE THEY START USE IN THEATERS AND WE SEE PROBLEM IN INTENSIVE CARE UNIT. THREE (3) DIFFERENT PATIENTS WERE INVOLVED. THE PROBLEM IS JUST THAT THERE IS A LEAK IN THE RED-BLUE CONNECTION. THAT IS ALSO WHAT THEY TRIED TO TAPE. IF THEY PUSH THE RED-BLUE CONNECTION FASTER THEN THE PROBLEM IS SOLVED BUT IF THEY DO NOT PUSH, IT DOES NOT CONNECT PROPERLY. THEY KNOW THE PRODUCT. THEY ARE SEEING THE PROBLEM FOR THE FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366162 ↗
• MalfunctionFeb 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT AIR LEAKAGE IN THE RED-BLUE CONNECTION 4 TIMES. THE LOT NUMBER IS NOT AVAILABLE BECAUSE THEY START USE IN THEATERS AND WE SEE PROBLEM IN INTENSIVE CARE UNIT. THREE (3) DIFFERENT PATIENTS WERE INVOLVED. THE PROBLEM IS JUST THAT THERE IS A LEAK IN THE RED-BLUE CONNECTION. THAT IS ALSO WHAT THEY TRIED TO TAPE. IF THEY PUSH THE RED-BLUE CONNECTION FASTER THEN THE PROBLEM IS SOLVED BUT IF THEY DO NOT PUSH, IT DOES NOT CONNECT PROPERLY. THEY KNOW THE PRODUCT. THEY ARE SEEING THE PROBLEM FOR THE FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366118 ↗
• MalfunctionFeb 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT AIR LEAKAGE IN THE RED-BLUE CONNECTION 4 TIMES. THE LOT NUMBER IS NOT AVAILABLE BECAUSE THEY START USE IN THEATERS AND WE SEE PROBLEM IN INTENSIVE CARE UNIT. THREE (3) DIFFERENT PATIENTS WERE INVOLVED. THE PROBLEM IS JUST THAT THERE IS A LEAK IN THE RED-BLUE CONNECTION. THAT IS ALSO WHAT THEY TRIED TO TAPE. IF THEY PUSH THE RED-BLUE CONNECTION FASTER THEN THE PROBLEM IS SOLVED BUT IF THEY DO NOT PUSH, IT DOES NOT CONNECT PROPERLY. THEY KNOW THE PRODUCT. THEY ARE SEEING THE PROBLEM FOR THE FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962856. One submission often covers many models, so check the product and lot details in each record.

• Z-1404-2015 · Mar 13, 2015 · Terminated
  Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.