PLEUR-EVAC IPN025424Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 34026704428909), received between Jun 8, 2020 and Apr 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Leak/Splash; Leak/Splash

  THE TEAM IN CARDIOLOGY (K2) HAS EXPERIENCED MAJOR LEAKING PLEUR-EVAC AT THE JUNCTION OF THE RED/BLUE CONNECTOR FROM LOT 74B2201471. IT APPEARS THAT 2 PLEUR-EVACS FROM THE SAME LOT HAD THE SAME ISSUE. WHEN THEY USED A DIFFERENT SET FROM A DIFFERENT LOT, THERE WAS NO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14221542 ↗
• MalfunctionApr 27, 2022Leak/Splash; Leak/Splash

  THE TEAM IN CARDIOLOGY ((B)(6)) HAS EXPERIENCED MAJOR LEAKING PLEUR-EVAC AT THE JUNCTION OF THE RED/BLUE CONNECTOR FROM LOT 74B2201471. IT APPEARS THAT 2 PLEUR-EVACS FROM THE SAME LOT HAD THE SAME ISSUE. WHEN THEY USED A DIFFERENT SET FROM A DIFFERENT LOT, THERE WAS NO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220467 ↗
• MalfunctionDec 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED TUESDAY EVENING (B)(6). THERE WAS NO ADVERSE EVENT TO THE PATIENT. THERE WERE 2 NURSES TROUBLESHOOTING THE CANISTER AND FOUND IT TO BE LEAKING AT THE CONNECTION SITE BETWEEN THE BLUE AND RED PORT SAME AS THE OTHERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11045884 ↗
• MalfunctionDec 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED ISSUE: WE RECENTLY HAVE BEEN NOTICING AIR LEAKS IN THE CONNECTION OF OUR PLEUR-EVAC. THIS BECOMES MISLEADING IN THE ASSESSMENT OF THE PATIENT AS BUBBLING OCCURS IN THE SYSTEM AND THE NURSES NEED TO DO ADDITIONAL INVESTIGATIONS TO SEE THE CAUSE (PT VS EQUIPMENT). IN THE ATTACHED PHOTO THE LEAK HAS BEEN FIXED WITH PINK TAPE. THIS MUST BE AFFECTING THE OR AS WELL AS A GOOD AMOUNT OF OUR PATIENT WITH THESE PLEUR-EVACS COME FROM OR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10986782 ↗
• MalfunctionJun 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  PER THE CUSTOMERS COMPLAINT REPORT A CHEST TUBE INSERTION WAS DONE ON A PATIENT. THE CHEST TUBE WAS FOUND TO BE LEAKING AT THE RED BLUE CONNECTION SITE. CUSTOMER REPORTED NO VISIBLE SIGNS OF DAMAGE TO TUBING OR CONNECTION SITE THOUGH PLEURAL FLUID DRIPPING. A NEW PLEUR-EVAC CHEST TUBE DRAINING SYSTEM WAS ATTACHED TO THE CHEST TUBE WHICH RESOLVED THE PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127929 ↗

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.