Parker H-PSTDL-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607411959479), received between Sep 17, 2025 and Sep 17, 2025 — 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 (K092886); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: DURING USE IN THE OPERATION ROOM, AIR LEAKAGE OCCURRED FROM THE BLUE CUFF; THE PATIENT WAS NOT REINTUBATED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078590 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092886. 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-