Parker H-PSTDL-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607411959486), received between Sep 21, 2018 and Dec 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION, THE BLUE CUFF DEFLATED AND COULD NOT BE REINFLATED. REINTUBATION WAS PERFORMED USING A NEW TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857640 ↗
• MalfunctionSep 21, 2018Difficult to Insert; Difficult to Insert

  REPORTER STATES THAT THE PATIENT EXPERIENCED AIRWAY TRAUMA THAT LED TO A RETURNED EMERGENCY VISIT. NO ADDITIONAL TREATMENT OR HOSPITALIZATION WAS REQUIRED. THERE WAS NO OTHER SERIOUS INJURY REPORTED. REPORTER WAS NOT INVOLVED IN THE EVENT, AND HAS NO FURTHER INFORMATION. REPORTER DID NOT REPORT A DEVICE DEFECT, ONLY THAT IT WAS DIFFICULT TO INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7900157 ↗

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-