Parker H-PFHV-85Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607411952760), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K984528); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 6, 2024Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  CUFF LEAKING DURING INTUBATION. PATIENT CANNOT BE VENTILATED ADEQUATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872621 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K984528. One submission often covers many models, so check the product and lot details in each record.

• Z-1399-2017 · Dec 16, 2016 · Terminated
  Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-