Parker Flex-Tip H-PFNC-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10749065031709), received between Jun 4, 2025 and Jan 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 16, 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.

• MalfunctionJan 24, 2026Gas/Air Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, IMMEDIATELY FOLLOWING NASOTRACHEAL INTUBATION, A LEAK WAS IDENTIFIED. THE PATIENT WAS REINTUBATED USING ORAL INTUBATION. NO DELAY IN THERAPY, HARM, OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS REFER TO 3004748541-2026-00022 FOR THE FIRST REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24174890 ↗
• MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, IMMEDIATELY AFTER INTUBATING THE SURGICAL PATIENT (WHO WAS IN THE SUPINE POSITION), A LEAK OCCURRED. (NO PRE-INTUBATION LEAK CHECK WAS PERFORMED.) THE DEVICE WAS REMOVED AND A DIFFERENT TRACHEAL TUBE WAS REINTUBATED, AND THERE WAS NO PROBLEM. THE REPORTER VERIFIED THAT THE LOWER PART OF THE CUFF WAS DAMAGED AND CONFIRMED THE LEAK. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146991 ↗