PLEUR-EVAC IPN028485Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 14026704631671), received between Mar 22, 2021 and Mar 17, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023Leak/Splash; Leak/Splash

  REPORTED ISSUE: LEAK IN SYSTEM BETWEEN RED CLAMP AND CORRUGATED TUBING TO COLLECTION CHAMBER. THE LEAK COULD NOT BE RESOLVED; THE DEVICE WAS REPLACED AND FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16568944 ↗
• MalfunctionMar 17, 2023Leak/Splash; Leak/Splash

  REPORTED ISSUE: LEAK IN SYSTEM BETWEEN RED CLAMP AND CORRUGATED TUBING TO COLLECTION CHAMBER. THE LEAK COULD NOT BE RESOLVED; THE DEVICE WAS REPLACED AND FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16568799 ↗
• MalfunctionJul 7, 2022Leak/Splash; Leak/Splash

  DAMAGE TO THE SAMPLE PORT AREA OUT OF THE PACKAGE CAUSING SYSTEM AIR LEAK THAT REQUIRED ADDITIONAL TAPING OF CONNECTIONS NOT USUALLY REQUIRED. THE DAMAGE WAS NOT FOUND PRIOR TO CONNECTING TO THE PATIENT AND THERE WAS NO PACKAGE DAMAGE. THE DAMAGE AND THE AIR LEAK OCCURRED AT THE RED/BLUE CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946261 ↗
• MalfunctionMar 30, 2022Leak/Splash; Leak/Splash

  THE PROBLEM PER PRODUCT CONCERN, AT LEAST 4 PLUS PATIENTS HAVE ARRIVED FROM THE OR WITH DUAL CHAMBER PLEUR-EVAC LOT 74L2101280 HAVE HAD AN AIR LEAK NOTED. WHEN FURTHER INVESTIGATED THE AIR LEAK WAS ISOLATED TO A SYSTEM PROBLEM. RED ATTACHMENT CONNECTOR LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 13953386 ↗
• MalfunctionMar 30, 2022Leak/Splash; Leak/Splash

  THE PROBLEM PER PRODUCT CONCERN, AT LEAST 4 PLUS PATIENTS HAVE ARRIVED FROM THE OR WITH DUAL CHAMBER PLEUR-EVAC LOT 74L2101280 HAVE HAD AN AIR LEAK NOTED. WHEN FURTHER INVESTIGATED THE AIR LEAK WAS ISOLATED TO A SYSTEM PROBLEM. RED ATTACHMENT CONNECTOR LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 13953311 ↗
• MalfunctionMar 30, 2022Leak/Splash; Leak/Splash

  THE PROBLEM PER PRODUCT CONCERN, AT LEAST 4 PLUS PATIENTS HAVE ARRIVED FROM THE OR WITH DUAL CHAMBER PLEUR-EVAC LOT 74L2101280 HAVE HAD AN AIR LEAK NOTED. WHEN FURTHER INVESTIGATED THE AIR LEAK WAS ISOLATED TO A SYSTEM PROBLEM. RED ATTACHMENT CONNECTOR LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 13953151 ↗
• MalfunctionMar 30, 2022Leak/Splash; Leak/Splash

  THE PROBLEM PER PRODUCT CONCERN, AT LEAST 4 PLUS PATIENTS HAVE ARRIVED FROM THE OPERATING ROOM WITH DUAL CHAMBER PLEUR-EVAC LOT 74L2101280 HAVE HAD AN AIR LEAK NOTED. WHEN FURTHER INVESTIGATED THE AIR LEAK WAS ISOLATED TO A SYSTEM PROBLEM. RED ATTACHMENT CONNECTOR LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 13952791 ↗
• MalfunctionJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AIR LEAK IN THE RED-BLEU CONNECTORS WITH CLAMP ABOVE CONNECTION THERE IS AN AIR LEAK WITH CLAMP BELOW CONNECTION THERE IS NO AIR LEAK SO IT IS IN THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213709 ↗
• MalfunctionJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AIR LEAK IN THE RED-BLEU CONNECTORS WITH CLAMP ABOVE CONNECTION THERE IS AN AIR LEAK WITH CLAMP BELOW CONNECTION THERE IS NO AIR LEAK SO IT IS IN THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213345 ↗
• MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  BIG AIR LEAK IN THE RED-BLEU CONNECTOR WITH CLAMP ABOVE CONNECTION THERE IS AN AIR LEAK WITH CLAMP BELOW CONNECTION THERE IS NO AIR LEAK, SO IT IS IN THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843299 ↗
• MalfunctionApr 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AIR LEAK IN THE RED-BLUE CONNECTOR WITH CLAMP ABOVE CONNECTION THERE IS AN AIR LEAK A WITH CLAMP BELOW CONNECTION THERE IS NO AIR LEAK, SO IT IS IN THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665599 ↗
• MalfunctionApr 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AIR LEAK IN THE RED-BLUE CONNECTOR WITH CLAMP ABOVE CONNECTION THERE IS AN AIR LEAK WITH CLAMP BELOW CONNECTION THERE IS NO AIR LEAK, SO IT IS IN THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665536 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT WAS CONNECTED TO THE DRAINAGE - NON DRAINAGE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546088 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT WAS CONNECTED TO THE DRAINAGE - NON DRAINAGE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546086 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT WAS CONNECTED TO THE DRAINAGE - NON DRAINAGE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546061 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT WAS CONNECTED TO THE DRAINAGE - NON DRAINAGE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546049 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT WAS CONNECTED TO THE DRAINAGE - NON DRAINAGE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11545977 ↗