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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10749065081803), received between Aug 28, 2025 and Jan 23, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Gas/Air Leak

  IT WAS REPORTED, IMMEDIATELY AFTER INTUBATION AN AIR LEAK OCCURRED. THE TUBE WAS REMOVED AND REINTUBATION WITH A NEW TUBE WAS PERFORMED. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24169057 ↗
• MalfunctionJan 8, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE DAYS AFTER INTUBATION, MEDICAL STAFF NOTED SUCTION WAS NOT FUNCTIONING SMOOTHLY. ON (B)(6) 2025, AN X-RAY REVEALED THE TUBE WAS KINKED BEYOND THE BACK TEETH. THE TUBE WAS REMOVED, AND RE-INTUBATION WAS NOT PERFORMED. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011551 ↗
• MalfunctionAug 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AIR LEAK OCCURRED AFTER INTUBATION DURING OPERATION. AIR WAS INJECTED AND CONTINUED TO BE USED DURING THE OPERATION. THE ANESTHESIOLOGIST SUSPECTS THE PATIENT MAY HAVE BITTEN THE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919521 ↗