Parker H-PFHV-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607411952753), received between Mar 1, 2024 and Sep 3, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599665 ↗
• MalfunctionJul 30, 2026Gas/Air Leak

  It was reported that the inflation port of the endotracheal tube (ETT) did not seem to be holding pressure, and they elected to extubate the patient. Multiple attempts were made to reintubate the patient using orogastric tube (OGT)/nasogastric tube (NGT) without success; the patient reportedly had a lot of secretions and blood in the oropharynx. Once the patient was successfully reintubated the ventilator alarm stopped and the carbon dioxide (CO2) trace was fine. No additional information, concerning patient outcome, was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50078240 ↗
• MalfunctionJan 23, 2026Gas/Air Leak

  IT WAS REPORTED:THAT DURING INTUBATION, THE INFLATING TUBE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172859 ↗
• MalfunctionOct 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "ETT LEAKS DURING PROCEDURE. IN REGARD TO THE INTUBATION, NEITHER OF THEM WAS DIFFICULT. ONE PATIENT HAD FULL DENTURES THAT WERE REMOVED PRIOR TO INTUBATION. THE OTHER PATIENT HAD ALL THEIR OWN TEETH. ON BOTH OCCASIONS THE TUBES WERE INFLATED WITH A SYRINGE, THE PRESSURE WAS CHECKED MULTIPLE TIMES WITH THE MANOMETER TO CHECK THE CUFF PRESSURE MULTIPLE TIMES. ONCE THE BUNG WAS PLACED ONTO THE TUBE THE PRESSURE WASN'T CHECKED HOWEVER, WE USED THE MACHINE VENTILATION TO CHECK IF THERE WAS A LEAK PRESENT. THE ETT WAS STRAIGHT OUT OF THE PACKING, THE CUFF WAS INFLATED PRIOR TO INSERTION AS PER PROTOCOL THEN DEFLATED PRIOR TO PLACEMENT. THE ETT WAS KEPT, AND WE SUBMERGED IT IN WATER AND INFLATED THE CUFF TO CHECK FOR A LEAK (THERE WAS NOT) AND THEN IT WAS DISCARDED IN THE MEDICAL WASTE AS PER PROTOCOL. " TWO INCIDENTS RECORDED FOR THIS COMPLAINT SO TWO REPORTS WILL BE SUBMITTED THE SECOND REPORT IS 3004748541-2025-00090.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318855 ↗
• MalfunctionOct 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "ETT LEAKS DURING PROCEDURE. IN REGARD TO THE INTUBATION, NEITHER OF THEM WAS DIFFICULT. ONE PATIENT HAD FULL DENTURES THAT WERE REMOVED PRIOR TO INTUBATION. THE OTHER PATIENT HAD ALL THEIR OWN TEETH. ON BOTH OCCASIONS THE TUBES WERE INFLATED WITH A SYRINGE, THE PRESSURE WAS CHECKED MULTIPLE TIMES WITH THE MANOMETER TO CHECK THE CUFF PRESSURE MULTIPLE TIMES. ONCE THE BUNG WAS PLACED ONTO THE TUBE THE PRESSURE WASN'T CHECKED HOWEVER, WE USED THE MACHINE VENTILATION TO CHECK IF THERE WAS A LEAK PRESENT. THE ETT WAS STRAIGHT OUT OF THE PACKING, THE CUFF WAS INFLATED PRIOR TO INSERTION AS PER PROTOCOL THEN DEFLATED PRIOR TO PLACEMENT. THE ETT WAS KEPT, AND WE SUBMERGED IT IN WATER AND INFLATED THE CUFF TO CHECK FOR A LEAK (THERE WAS NOT) AND THEN IT WAS DISCARDED IN THE MEDICAL WASTE AS PER PROTOCOL. " TWO INCIDENTS RECORDED FOR THIS COMPLAINT SO TWO REPORTS WILL BE SUBMITTED THE FIRST REPORT IS 3004748541-2025-00089.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318853 ↗
• MalfunctionOct 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: SEVERAL HOURS AFTER INFLATION, THE INFLATING TUBE DISCONNECTED (DURING USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230365 ↗
• MalfunctionAug 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE PATIENT WAS PREPARED FOR EXTUABATION, AT 2PM, THE CUFF PRESSURE WAS CHECKED AND NO PROBLEMS WERE FOUND; THE CUFF PRESSURE WAS CHECKED AGAIN AT 3PM AND A DECREASE IN CUFF PRESSURE WAS NOTED. AFTER EXTUBATION, THE INFLATING TUBE CAME OFF. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919522 ↗
• MalfunctionJul 2, 2024Mechanical Problem; Mechanical Problem

  FREQUENTLY RECEIVE ALARMS FOR ELEVATED CUFF PRESSURE OR LEAKAGE. OUR PROBLEM IS LEAKAGE PAST THE CUFF AT RELATIVELY HIGH VENTILATOR PRESSURES. EXPERIENCE LEAKAGE PAST THE CUFF WITH PARKER TUBES DUE TO THE ELONGATED CUFF WHEN THE TUBE IS SOMEWHAT SMALL RELATIVE TO THE TRACHEAL SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660370 ↗
• MalfunctionJun 12, 2024Connection Problem; Connection Problem

  MALFUNCTION, THE INFLATING TUBE CAME LOOSE FROM THE BASE/HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518874 ↗
• MalfunctionJun 7, 2024Deflation Problem; Unintended Deflation; Deflation Problem; Unintended Deflation

  THE INFLATION TUBE CAME OFF FROM THE BASE, CONNECTION TO THE TRACHEAL TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486619 ↗
• MalfunctionApr 5, 2024Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem

  THREE DAYS AFTER INTUBATION, IT WAS FOUND THAT THE INFLATING TUBE HAS BEEN REMOVED FROM THE TRACHEAL TUBE ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055615 ↗
• MalfunctionMar 1, 2024Gas/Air Leak; Gas/Air Leak

  AIR WAS LEAKING FROM THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823007 ↗

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-