Parker Flex-Tip H-PSTDL-35Recalls & reported problems

Salter Labs · Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 35 Fr, O.D 10.5mm, I.D 4.0mm · Class 2

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 10749065851406), received between Oct 11, 2023 and Oct 11, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Integrity Problem1

Patient problems

Unspecified Respiratory Problem1

Recent adverse event reports

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

MalfunctionOct 11, 2023Material Integrity Problem; Material Integrity Problem
THE PATIENT WAS DE-INTUBATED AND RE -INTUBATED WITH ANOTHER TUBE.
Patient problems: Unspecified Respiratory Problem
MAUDE report 17914125 ↗

Device details

UDI-DI	`10749065851406`
Brand	Parker Flex-Tip
Model	H-PSTDL-35
Company	Salter Labs
Product code	CBI · Tube, Tracheal/Bronchial, Differential Ventilation (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, 2019

Device type (GMDN): Endobronchial tube

A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.