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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10749065801807), received between Aug 1, 2025 and Dec 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT EIGHT DAYS AFTER INTUBATION, THE INFLATING TUBE DETACHED, REQUIRING REINTUBATION. THREE DAYS LATER, THE INFLATION TUBE OF THE SECOND DEVICE ALSO DETACHED. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00150 FOR THE FIRST REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857842 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT EIGHT DAYS AFTER INTUBATION, THE INFLATING TUBE DETACHED, REQUIRING REINTUBATION. THREE DAYS LATER, THE INFLATION TUBE OF THE SECOND DEVICE ALSO DETACHED. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00151 FOR THE SECOND REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857833 ↗
• MalfunctionAug 1, 2025Connection Problem; Connection Problem

  IT WAS REPORTED, ON THE FIRST 14 DAYS OF USE, THE INFLATING TUBE HAD FALLEN OUT OF THE TAPE USED TO HOLD THE TUBE IN PLACE. THE PATIENT WAS REINTUBATED. IT WAS ADDITIONALLY REPORTED; THE PATIENT HAD SEIZURES AND A BITE BLOCK WAS USED (NO ADDITIONAL INFORMATION WAS REPORTED CONCERNING THE SEIZURES); NO INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22692754 ↗