Mallinckrodt 125028Recalls & reported problems

Covidien LP · Endobronchial Tube Left;Endobronchial Suction Catheter;Endobronchial Tube Accessories · Class 2

All models of Mallinckrodt (73)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884522008710), received between May 5, 2017 and May 5, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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 18, 2026.

Most reported problems

Device problems

Manufacturing, Packaging or Shipping Problem1

Patient problems

Extubate1

Recent adverse event reports

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

InjuryMay 5, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
MEDTRONIC RECEIVED A REPORT THE INNER DIAMETER OF THE TRACHEOSTOMY TUBE WAS SMALLER THAT NORMAL. CUSTOMER INDICATED THERE WAS NO PATIENT INJURY WITH THIS EVENT.
Patient problems: Extubate
MAUDE report 6549198 ↗

Device details

UDI-DI	`30884522008710`
Brand	Mallinckrodt
Model	125028
Company	Covidien LP
Product code	BTS · TUBE, BRONCHIAL (W/WO CONNECTOR)
Class	Class 2
FDA submission	K771219
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 7, 2026

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.

Other TUBE, BRONCHIAL (W/WO CONNECTOR) devices

Shiley 125037
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1 death209 reports
Shiley 125035
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Shiley 126035
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50 reports
Mallinckrodt 125037
Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)
49 reports
Mallinckrodt 126037
Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)
47 reports
Shiley 125039
Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)
40 reports
Shiley 126039
Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)
39 reports
Mallinckrodt 125035
Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)
34 reports

All TUBE, BRONCHIAL (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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