Parker H-PFST-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607411958014), received between Jul 10, 2018 and Nov 14, 2025 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT IMMEDIATELY AFTER INTUBATION, AN AIR LEAK OCCURRED. THE TUBE WAS REMOVED, AND THE PATIENT WAS REINTUBATED WITH A NEW TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560518 ↗
• MalfunctionSep 25, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED, THE PILOT BALLOON DEFLATED IMMEDIATELY AFTER INTUBATION, (THERE WAS NO PROBLEM WITH THE CUFF TEST PRIOR TO INTUBATION.) THE PATIENT WAS REINTUBATED, THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151445 ↗
• MalfunctionSep 27, 2024Loose or Intermittent Connection; Material Integrity Problem; Incomplete or Inadequate Connection; Loose or Intermittent Connection; Material Integrity Problem; Incomplete or Inadequate Connection

  CONNECTION BETWEEN THE PILOT BALLOON AND THE INFLATING TUBE WAS RIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326480 ↗
• MalfunctionSep 6, 2024Gas/Air Leak; Gas/Air Leak

  THERE IS A LEAK FROM THE CONNECTION BETWEEN THE INFLATING TUBE AND THE PILOT BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163915 ↗
• DeathJul 10, 2018Material Integrity Problem; Material Integrity Problem

  PATIENT UNDERWENT SURGERY AND SUBSEQUENTLY DEVELOPED DECREASED OXYGEN SATURATION. X-RAY REVEALED PNEUMOMEDIASTINUM. PATIENT WAS INTUBATED AND PLACED ON VENTILATOR. PATIENT WAS DETERMINED TO HAVE A SUBACUTE RIGHT ACA INFARCT AND CHRONIC RIGHT MCA INFARCT. PATIENT EXPIRED ON (B)(6) 2018.

  Patient problems: Death

  MAUDE report 7674163 ↗

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-