PLEUR-EVAC IPN025425Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704417469), received between Sep 28, 2023 and Sep 28, 2023 — classified as 3 malfunctions.

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

• 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 ↗