HUDSON RCI IPN048958Recalls & reported problems

Teleflex Incorporated · ET TUBE, CUFFED, SPIRAL-FLEX 6.5 · Class 2

All models of HUDSON RCI (152)

Data updated Oct 18, 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 14026704617064), received between Nov 21, 2022 and Nov 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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 18, 2026.

Most reported problems

Device problems

Gas/Air Leak1
Inflation Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionNov 21, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak
IT WAS REPORTED "ONCE THE TUBE ENTERED THE PATIENT, THE BALLOON DID NOT INFLATE, APPARENTLY IT HAD SOME LEAK." PATIENT CONDITION UNKNOWN AT TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO COMPLAINANT, NO RESPONSE AT TIME OF REPORT.
Patient problems: Insufficient Information
MAUDE report 15833753 ↗

Device details

UDI-DI	`14026704617064`
Brand	HUDSON RCI
Model	IPN048958
Catalog no.	5-12613
Company	Teleflex Incorporated
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K844296
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Sep 29, 2025

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

An armoured 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 is wire reinforced to prevent kinking during patient movement and 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) have a built-in pilot balloon. It is typically made of plastic or rubber and 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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