Skip to content

PLEUR-EVAC IPN028454Recalls & reported problems

Teleflex Incorporated · PLEUR-EVAC DRY/WET CONTINUOUS REINFUSION LATEX FREE · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704631350), received between Nov 17, 2021 and Mar 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 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

Device problems

  • Leak/Splash2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

    REPORTED ISSUE: LEAK WOULD RESOLVE WHEN USING PRESSURE TO HOLD THE RED CLAMP AND TUBE TOGETHER TIGHTLY. WATERPROOF TAPE ATTEMPTED AND DID NOT HELP. CHANGED DRAINAGE SYSTEMS WHICH FIXED THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16624137 ↗
  • InjuryNov 17, 2021Leak/Splash; Leak/Splash

    MEDWATCH #(B)(4). LARGE PNEUMOTHORAX NOTED ON ROUTINE MORNING CHEST X-RAY. DETERMINED TO BE CAUSED BY AN AIR LEAK IN THE PLEUR-EVAC. PATIENT WAS NOT IN DISTRESS BUT DID HAVE SOME PAIN AND COUGHING. AIR LEAK FIXED AND LUNG RE-EXPANDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12829231 ↗

Other APPARATUS, AUTOTRANSFUSION devices

All APPARATUS, AUTOTRANSFUSION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.