Parker Flex-Tip H-PFTVPU-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10749065101808), received between Jun 10, 2025 and Sep 14, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Gas/Air Leak

  It was reported that one week after intubation, the automatic cuff pressure monitor alarm sounded continuously. The tube was extubated, and the patient was immediately reintubated with a new tube. There was no reported delay in therapy, harm, or injury associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756313 ↗
• MalfunctionMar 19, 2026Gas/Air Leak

  IT WAS REPORTED THAT INTUBATION WAS PERFORMED ON (B)(6) 2026, AT 10:00 PM. ON (B)(6) 2026, THE ENDOTRACHEAL TUBE WAS EXCHANGED DUE TO DECREASED VENTILATION VOLUME. FOLLOWING EXTUBATION, THE MEDICAL STAFF INSPECTED THE DEVICE AND NOTED THAT THE CUFF WAS UNABLE TO BE INFLATED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24638800 ↗
• MalfunctionJun 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, ON (B)(6) 2025 IN THE MORNING, INTUBATION OF THE PATIENT WAS PERFORMED. SUCTIONING WAS PERFORMED EVERY HOUR AFTER THE START OF USE. ON (B)(6) 2025 AT 10:00 A.M., SUCTIONING WAS PERFORMED DUE TO THE PATIENT CHOKING; A CUFF LEAK OCCURRED AFTER SUCTIONING. THE TIDAL VOLUME AND SPO2 OF THE PATIENT DROPPED. THE DOCTOR REINTUBATED THE PATIENT WITH A NEW TUBE. IT WAS ADDITIONALLY REPORTED, THE CUFF HAS CONTINUALLY INFLATED FOR OVER 100 HOURS WHEN THE SUCTION END OF THE TUBE WAS CAPPED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22302957 ↗
• MalfunctionJun 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, AFTER INTUBATION IN THE ER, THE PATIENT WAS TRANSFERRED TO THE WARD. IMMEDIATELY AFTER PLACING THE PATIENT ON THE VENTILATOR IN THE WARD, A LOW PRESSURE ALARM ON THE VENTILATOR WENT OFF AND A CUFF LEAK OCCURRED (WITHIN THE FIRST HOUR OF USE). ADDITIONAL AIR WAS INJECTED, BUT THE LEAK WAS NOT RESOLVED. THE PATIENT WAS RE-INTUBATED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177068 ↗