Parker Flex-Tip H-PFST-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10749065801753), received between Jan 24, 2026 and Jun 26, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT, AFTER MEDICAL STAFF CONNECTED A CUFF PRESSURE GAUGE, THE PRESSURE DECREASED BY APPROXIMATELY 20 MMHG. THE TUBE WAS SUBSEQUENTLY EXTUBATED AND REPLACED 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 25637556 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED, IMMEDIATELY AFTER INTUBATION NO INCREASE IN PERIPHERAL OXYGEN SATURATION (SPO2) WAS OBSERVED; THE TUBE WAS REMOVED AND REINTUBATION WAS PERFORMED WITH A NEW TUBE. THE CUFF REPORTEDLY HAD A LEAK; HOWEVER, THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24408163 ↗
• MalfunctionJan 24, 2026Separation Problem

  IT WAS REPORTED THAT ONE WEEK AFTER INTUBATION, THE INFLATION TUBE DETACHED, AND REINTUBATION WAS PERFORMED USING A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS REFER TO 3004748541-2026-00019 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00020 FOR THE SECOND REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24174866 ↗
• MalfunctionJan 24, 2026Separation Problem

  IT WAS REPORTED THAT SEVERAL DAYS AFTER INTUBATION, THE INFLATION TUBE DETACHED, AND REINTUBATION WAS PERFORMED USING A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS REFER TO 3004748541-2026-00019 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00021 FOR THE THIRD REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24174865 ↗
• MalfunctionJan 24, 2026Deflation Problem

  IT WAS REPORTED THAT SEVERAL HOURS AFTER INTUBATION, MEDICAL STAFF NOTICED THE CUFF WAS DEFLATED. THE PATIENT WAS REINTUBATED WITH A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS REFER TO 3004748541-2026-00020 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00021 FOR THE THIRD REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173625 ↗