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PLEUR-EVAC IPN028449Recalls & reported problems

Teleflex Incorporated · PLEUR-EVAC ADULT-PEDIATRIC WET LATEX FREE · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34026704631309), received between Mar 27, 2023 and Mar 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • Pneumothorax1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    REPORTED ISSUE: IT WAS REPORTED THAT THERE WAS A RUPTURE IN THE DRAINAGE TUBE WHERE AIR ENTERED. THIS RESULTED IN THE INGRESS OF AIR IN THE DRAINAGE RESULTING IN PNEUMOTHORAX AND SUBCUTANEOUS EMPHYSEMA, DETECTED THROUGH X-RAY PERFORMED THE DAY AFTER. THE PLEUREVAC WAS PROMPTLY REPLACED WITH NO CONSEQUENCES FOR THE PATIENT, OTHER THAN MAINTAINING THE DRAINAGE FOR AN ADDITIONAL DAY AND A CONSEQUENT INCREASE IN HOSPITALIZATION.

    Patient problems: Pneumothorax

    MAUDE report 16623253 ↗

Other BOTTLE, COLLECTION, VACUUM devices

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