PLEUR EVAC IPN010597Recalls & reported problems
Teleflex Incorporated · PE ADULT-PED WET LF · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34026704428824), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED " FAIL TO FUNCTION / DEFECTIVE, LEAKAT RED/BLUE JUNCTION. DURING USE." TO CONTINUE THERAPY, THE CANISTER WAS CHANGED. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19542888 ↗
Other BOTTLE, COLLECTION, VACUUM devices
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- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- EXPRESS 4000-100NAtrium Medical Corporation · Bottle, Collection, Vacuum2 recalls30 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.