PLEUR-EVACRecalls & reported problems across all models

We found 15 models of PLEUR-EVAC by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2020 and Mar 25, 2026 — classified as 3 injuries, 143 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (73 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

PLEUR-EVAC recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 12, 2021Terminated

   Teleflex is recalling this product due to a lack of assurance of sterility.

   Z-1298-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported PLEUR-EVAC problems

PLEUR-EVAC models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PLEUR-EVAC IPN028442

  BOTTLE, COLLECTION, VACUUM
  54 reports
• PLEUR-EVAC IPN028459

  CATHETER, IRRIGATION
  1 recall0 reports
• PLEUR-EVAC IPN028484

  BOTTLE, COLLECTION, VACUUM
  29 reports
• PLEUR-EVAC IPN028446

  BOTTLE, COLLECTION, VACUUM
  19 reports
• PLEUR-EVAC IPN028485

  APPARATUS, AUTOTRANSFUSION
  17 reports
• PLEUR-EVAC IPN028441

  APPARATUS, AUTOTRANSFUSION
  8 reports
• PLEUR-EVAC IPN025424

  BOTTLE, COLLECTION, VACUUM
  5 reports
• PLEUR-EVAC IPN025425

  APPARATUS, AUTOTRANSFUSION
  3 reports
• PLEUR EVAC IPN010586

  BOTTLE, COLLECTION, VACUUM
  3 reports
• PLEUR-EVAC IPN028454

  APPARATUS, AUTOTRANSFUSION
  2 reports
• PLEUR-EVAC IPN028472

  CATHETER, IRRIGATION
  2 reports
• PLEUR-EVAC IPN011527

  CATHETER, IRRIGATION
  1 report
• PLEUR-EVAC A-6002-08LF

  BOTTLE, COLLECTION, VACUUM
  1 report
• PLEUR EVAC IPN010597

  BOTTLE, COLLECTION, VACUUM
  1 report
• PLEUR-EVAC IPN028449

  BOTTLE, COLLECTION, VACUUM
  1 report

Recent PLEUR-EVAC adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT "CHEST DRAIN, BLUE-COLOURED FLUID, WHICH TYPICALLY CONCERNS THE SUCTION CONTROL CHAMBER, DID NOT CHANGE COLOUR. BUBBLING OBSERVED IN THE DRAIN, EMPHYSEMA OBSERVED IN THE PATIENT. MEASURES TAKEN: DRAIN CHANGED + PATIENT TREATED IN INTENSIVE CARE."

  Patient problems: Pulmonary Emphysema

  MAUDE report 24683458 ↗
• 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 ↗
• MalfunctionJun 14, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED " FAIL TO FUNCTION / DEFECTIVE, LEAKAT RED/BLUE JUNCTION. DURING USE." TO CONTINUE THERAPY, THE CANISTER WAS CHANGED. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542888 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THAT, "WE WERE PLACING ONE OF THEM YESTERDAY AND THE KNOB BROKE OFF OF THE STYLET AFTER PLACEMENT, CAUSING THE USE OF HEMOSTATS TO REMOVE STYLET, WHICH CAUSED DISPLACEMENT." ADDITIONAL INFORMATION RECEIVED STATES THAT THE INCIDENT "LED TO BABY HAVING TO HAVE ANOTHER CHEST TUBE TO BE PLACED. BABY IS CRITICAL BUT STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941940 ↗
• MalfunctionSep 28, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE ON PATIENT, "CONNECTIONS ARE NOT SECURE BETWEEN CHEST DRAIN CATHETER AND THE DRAINAGE TUBE. THE DRAINAGE TUBE WILL SPONTANEOUSLY DISCONNECT FROM THE CATHETER". AS A RESULT, THE "STAFF HAVE TAPED THE CONNECTIONS OR USED CABLE TIES". THE ISSUE OCCURRED WHILE THE PATIENT WAS LYING IN BED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE AND DISCHARGED HOME".

  Patient problems: Distress; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835902 ↗
• MalfunctionSep 28, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE ON PATIENT, "CONNECTIONS ARE NOT SECURE BETWEEN CHEST DRAIN CATHETER AND THE DRAINAGE TUBE. THE DRAINAGE TUBE WILL SPONTANEOUSLY DISCONNECT FROM THE CATHETER". AS A RESULT, THE "STAFF HAVE TAPED THE CONNECTIONS OR USED CABLE TIES". THE ISSUE OCCURRED WHILE THE PATIENT WAS LYING IN BED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE AND DISCHARGED HOME".

  Patient problems: Distress; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835715 ↗
• MalfunctionSep 28, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE ON PATIENT, "CONNECTIONS ARE NOT SECURE BETWEEN CHEST DRAIN CATHETER AND THE DRAINAGE TUBE. THE DRAINAGE TUBE WILL SPONTANEOUSLY DISCONNECT FROM THE CATHETER". AS A RESULT, THE "STAFF HAVE TAPED THE CONNECTIONS OR USED CABLE TIES". THE ISSUE OCCURRED WHILE THE PATIENT WAS LYING IN BED. NO PATIENT HARM OR INJURY HOWEVER THE CHEST DRAIN HAD TO BE PLACED ON SUCTION AS THE PATIENT'S PNEUMOTHORAX HAD INCREASED. THE PATIENT STATUS IS REPORTED AS "STABLE AND DISCHARGED HOME".

  Patient problems: Distress; No Clinical Signs, Symptoms or Conditions; Pneumothorax

  MAUDE report 17835662 ↗
• 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 ↗
• MalfunctionJun 6, 2023Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT "THE WATER SEAL CHAMBER BECOMES OVERFILLED WITH WATER AFTER THE PLEURA-VAC HAS BEEN SET UP. DURING SET UP IN THESE INSTANCES, THE WATER SEAL CHAMBER HAS BEEN SET TO THE RECOMMENDED 2 CM AND THE SUCTION CONTROL CHAMBER HAS BEEN SET TO THE RECOMMENDED 20 CM OF WATER. ABOUT AN HOUR AND A HALF AFTER SET UP, IT HAS BEEN NOTICED THAT THE WATER SEAL CHAMBER IS WAY OVER THE 2 CM MARK". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION, SPECIFICALLY REGARDING PATIENT DETAILS. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070241 ↗
• MalfunctionJun 6, 2023Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT "THE WATER SEAL CHAMBER BECOMES OVERFILLED WITH WATER AFTER THE PLEURA-VAC HAS BEEN SET UP. DURING SET UP IN THESE INSTANCES, THE WATER SEAL CHAMBER HAS BEEN SET TO THE RECOMMENDED 2 CM AND THE SUCTION CONTROL CHAMBER HAS BEEN SET TO THE RECOMMENDED 20 CM. OF WATER. ABOUT AN HOUR AND A HALF AFTER SET UP, IT HAS BEEN NOTICED THAT THE WATER SEAL CHAMBER IS WAY OVER THE 2 CM MARK". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION, SPECIFICALLY REGARDING PATIENT DETAILS. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17070169 ↗
• 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 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE CHEST TUBE CONTAINER WAS BUBBLING A LARGE AMOUNT WHEN APPLIED TO SUCTION EVEN WHEN THE TUBING TO THE PATIENT WAS CLAMPED SUGGESTING AIR ENTRY INTO THE CONTAINER. THERE WAS NO VISIBLE DAMAGE TO THE CONTAINER. THE CONTAINER WAS CHANGED FOR A NEW ONE AND THE BUBBLING SLOWED SIGNIFICANTLY. THE NEW CONTAINER ALSO DID NOT BUBBLE WHEN CLAMPED". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16833529 ↗
• 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, 2023Leak/Splash; Leak/Splash

  REPORTED ISSUE: LEAK WOULD RESOLVE WHEN USING PRESSURE TO HOLD THE RED CLAMP AND TUBE TOGETHER TIGHTLY. WATERPROOF TAPE ATTEMPTED AND DID NOT HELP. CHANGED DRAINAGE SYSTEMS WHICH FIXED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624137 ↗

Other Teleflex Incorporated products

• ARROW1,494 models · 9,043 reports · 62 recalls
• RUSCH220 models · 436 reports · 130 recalls
• WECK97 models · 3,790 reports · 1 recall
• HUDSON RCI152 models · 1,461 reports · 7 recalls
• LANGSTON4 models · 15 reports · 5 recalls
• LMA AIRWAY MANAGEMENT47 models · 139 reports
• UROLIFT13 models · 137 reports
• GIBECK7 models · 32 reports · 2 recalls