VENTISEAL ORAL/NASAL(ON)ET TUBE ID 3.5 - STERILE -USA 038-971-035URecalls & reported problems

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 05055788729266), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 malfunction.

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.

Reports received per month

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

Most reported problems

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.

MalfunctionNov 13, 2024
ANESTHESIA TEAM PLACING VENTISEAL CUFFED ET TUBES ON NEONATES. UNABLE TO EXTUBATE TWO NICU PATIENTS WHO WERE INTUBATED BY ANESTHESIA TEAM, USING CUFFED ETTS. THE NICU TEAM HAVE TRIED TO DEFLATE THE TUBES MANUALLY WHICH COULD PUT THOSE BABIES AT RISK OF TRACHEAL/ESOPHAGEAL PERFORATION. VENTISEAL BEING USED AND THESE TUBE CUFFS ARE NOT FULLY UNIFORM AND HAVE EDGES COMPARED WITH A SMOOTHER CUFF ON THE COVIDIEN TUBES USED PREVIOUSLY. TUBE SIZES NOTED TO HAVE THIS ISSUE WERE LESS THEN 4.0 MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672981 ↗

Device details

UDI-DI	`05055788729266`
Brand	VENTISEAL ORAL/NASAL(ON)ET TUBE ID 3.5 - STERILE -USA
Model	038-971-035U
Company	Flexicare Medical Limited
Product code	BTR · Tube, Tracheal (W/Wo Connector)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 30, 2024

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.

Other Tube, Tracheal (W/Wo Connector) devices

Shiley 18875
Covidien LP · Tube, tracheal (w/wo connector)
4 deaths570 reports
RUSCH IPN041476
Teleflex Incorporated · Tube, tracheal (w/wo connector)
10 recalls0 reports
Shiley 18775
Covidien LP · Tube, tracheal (w/wo connector)
489 reports
Shiley 18770
Covidien LP · Tube, tracheal (w/wo connector)
2 deaths434 reports
Shiley 18880
Covidien LP · Tube, tracheal (w/wo connector)
2 deaths370 reports
Shiley 18780
Covidien LP · Tube, tracheal (w/wo connector)
3 deaths286 reports
Shiley 18770S
Covidien LP · Tube, tracheal (w/wo connector)
273 reports
Shiley 18780S
Covidien LP · Tube, tracheal (w/wo connector)
251 reports

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.

How reports and recalls are matched · Editorial policy · Report an error on this page