PLEUR EVAC IPN010586Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34026704428794), received between Feb 4, 2020 and Feb 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2023Suction Problem; Suction Problem

  REPORTED EVENT: THE ORANGE INDICATOR PIECE WHICH INDICATES IF SUCTION IS BEING ADEQUATELY MAINTAINED AT THE ORDERED RATE DOES NOT SHOW IN A WINDOW. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373021 ↗
• MalfunctionFeb 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN ISSUE OCCURRED WITH 2 SEPARATE PATIENTS; IN BOTH CASES ONCE INSTALLED THE DRAIN BEGAN TO FOAM DURING ACTIVATION. THE JUNCTIONS WERE CHECKED, AND EVERYTHING SEEMED TO BE IN ORDER. FURTHER INFORMATION INDICATES THAT THE FOAM WAS PRODUCED CONTINUOUSLY IN THE AREA FOR BLOOD COLLECTION. THE FOAM WAS LARGE ENOUGH TO SPREAD TO NEIGHBORING COMPARTMENTS. DRAINS WERE INSTALLED FOR BLOOD EFFUSIONS. WE USED THE SOLUTION THAT WAS PROVIDED WITH THE PLEUR-EVAC UNIT. FOAMING OCCURRED WHEN IT WAS CONNECTED TO THE PATIENT AND ON ACTIVATION OF THE SUCTION. WE CHECKED ALL THE CONNECTIONS SEVERAL TIMES, BUT THE FOAM CONTINUED TO OCCUR DESPITE EVERYTHING. WE CHANGED THE UNITS IN BOTH CASES AND THE PROBLEM WAS RESOLVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9666025 ↗
• MalfunctionFeb 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN ISSUE OCCURRED WITH 2 SEPARATE PATIENTS; IN BOTH CASES ONCE INSTALLED THE DRAIN BEGAN TO FOAM DURING ACTIVATION. THE JUNCTIONS WERE CHECKED, AND EVERYTHING SEEMED TO BE IN ORDER. FURTHER INFORMATION INDICATES THAT THE FOAM WAS PRODUCED CONTINUOUSLY IN THE AREA FOR BLOOD COLLECTION. THE FOAM WAS LARGE ENOUGH TO SPREAD TO NEIGHBORING COMPARTMENTS. DRAINS WERE INSTALLED FOR BLOOD EFFUSIONS. WE USED THE SOLUTION THAT WAS PROVIDED WITH THE PLEUR-EVAC UNIT. FOAMING OCCURRED WHEN IT WAS CONNECTED TO THE PATIENT AND ON ACTIVATION OF THE SUCTION. WE CHECKED ALL THE CONNECTIONS SEVERAL TIMES, BUT THE FOAM CONTINUED TO OCCUR DESPITE EVERYTHING. WE CHANGED THE UNITS IN BOTH CASES AND THE PROBLEM WAS RESOLVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9665845 ↗