PLEUR-EVAC IPN028446Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 34026704631279), received between Mar 29, 2021 and Jun 6, 2023 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND BETWEEN THE RED AND BLUE FAST CLICK CONNECTOR WHILE USING IN PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759092 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND BETWEEN THE RED AND BLUE FAST CLICK CONNECTORS WHILE USING IN THE PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759044 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND BETWEEN THE RED AND BLUE FAST CLICK CONNECTOR WHILE USING IN PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759012 ↗
• MalfunctionOct 26, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AIR LEAKS ON CONNECTION TUBING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677012 ↗
• MalfunctionOct 26, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AIR LEAKS ON CONNECTION TUBING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676985 ↗
• MalfunctionSep 23, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER MENTIONED THAT THE CLINICAL STAFF HEARD A HISSING NOISE (POTENTIAL AIR LEAK) AT THE SITE OF THE QUICK DISCONNECT. ADDITIONAL INFORMATION INDICATES THAT THE NOISE WAS COMING FROM THE RED/BLUE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469631 ↗
• MalfunctionAug 12, 2022Leak/Splash; Leak/Splash

  AIR LEAK AT THE QUICK DISCONNECT FEATURE ON THE PATIENT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218681 ↗
• MalfunctionAug 1, 2022Leak/Splash; Leak/Splash

  WE HAVE HAD 3 CASES IN THE LAST WEEK IN WHICH WE HAVE IDENTIFIED A DEFECT IN THE PLEUR-EVAC, NO LOT NUMBERS OR DEFECTIVE PRODUCT A VAILABLE. THE IS A DEFECT AT THE JUNCTION OF THE RUBBER TUBING TO THE CORRUGATED TUBING (RED TO BLUE CONNECTION). WE HAVE HAD TO CHANGE OUT THESE 3 VACS FOR THESE PATIENTS WITHIN 24 HOURS POST OP. WE HAVE ALSO COMPLETED FDA FORM 3500.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138469 ↗
• MalfunctionAug 1, 2022Leak/Splash; Leak/Splash

  WE HAVE HAD 3 CASES IN THE LAST WEEK IN WHICH WE HAVE IDENTIFIED A DEFECT IN THE PLEUR-EVAC, NO LOT NUMBERS OR DEFECTIVE PRODUCT A VAILABLE. THE IS A DEFECT AT THE JUNCTION OF THE RUBBER TUBING TO THE CORRUGATED TUBING (RED TO BLUE CONNECTION). WE HAVE HAD TO CHANGE OUT THESE 3 VACS FOR THESE PATIENTS WITHIN 24 HOURS POST OP. WE HAVE ALSO COMPLETED FDA FORM 3500.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138460 ↗
• MalfunctionAug 1, 2022Leak/Splash; Leak/Splash

  WE HAVE HAD 3 CASES IN THE LAST WEEK IN WHICH WE HAVE IDENTIFIED A DEFECT IN THE PLEUR-EVAC, NO LOT NUMBERS OR DEFECTIVE PRODUCT AV AILABLE. THE IS A DEFECT AT THE JUNCTION OF THE RUBBER TUBING TO THE CORRUGATED TUBING (RED TO BLUE CONNECTION). WE HAVE HAD TO CHANGE OUT THESE 3 VACS FOR THESE PATIENTS WITHIN 24 HOURS POST OP. WE HAVE ALSO COMPLETED FDA FORM 3500.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138407 ↗
• MalfunctionJul 20, 2022Leak/Splash; Leak/Splash

  AN AIR LEAK AT THE QUICK DISCONNECT FEATURE ON THE PATIENT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069836 ↗
• MalfunctionApr 14, 2022Leak/Splash; Leak/Splash

  AIR HEARD HISSING FROM PLEUREVAC. AIR LEAK NOTED. ENTIRE PLEUREVAC CHANGED AND THEN NO ISSUE. NO VISIBLE CRACK BUT AIR LEAK FROM RED/BLUE CONNECTOR. THE SAME ISSUE HAS HAPPENED WITH ALL OF THESE CHEST DRAINS. 2 OF THE 6 WERE USED IN A CLINICAL SETTING. THE REMAINING DRAINS WERE TESTED OUTSIDE OF USING ON A PATIENT AND THE CUSTOMER FOUND SIMILAR ISSUES ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116024 ↗
• MalfunctionApr 14, 2022Leak/Splash; Leak/Splash

  AIR HEARD HISSING FROM PLEUREVAC. AIR LEAK NOTED. ENTIRE PLEUREVAC CHANGED AND THEN NO ISSUE. NO VISIBLE CRACK BUT AIR LEAK FROM RED/BLUE CONNECTOR. THE SAME ISSUE HAS HAPPENED WITH ALL OF THESE CHEST DRAINS. 2 OF THE 6 WERE USED IN A CLINICAL SETTING. THE REMAINING DRAINS WERE TESTED OUTSIDE OF USING ON A PATIENT AND THE CUSTOMER FOUND SIMILAR ISSUES ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116007 ↗
• MalfunctionApr 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RED CONNECTION HAD A LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11687832 ↗
• MalfunctionApr 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RED CONNECTION HAD A LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11687350 ↗
• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE RED CONNECTION HAD A LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581074 ↗