Parker Flex-Tip H-PFST-65Recalls & reported problems

Salter Labs · Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 6.5mm · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10749065801654), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Integrity Problem1
Material Puncture/Hole1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 25, 2024Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem
(B)(6)-JAPAN_IT WAS REPORTED THAT THE INCIDENT WAS DISCOVERED DURING PATIENT USE, THERE WAS A HOLE IN THE BODY OF THE TRACHEAL TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539429 ↗

Device details

UDI-DI	`10749065801654`
Brand	Parker Flex-Tip
Model	H-PFST-65
Company	Salter Labs
Product code	BTR · Tube, Tracheal (W/Wo Connector)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 19, 2020

Device type (GMDN): Basic endotracheal tube, single-use

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

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All Tube, Tracheal (W/Wo Connector) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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