Mallinckrodt 86445Recalls & reported problems
Covidien LP · Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye · Class 2
All models of Mallinckrodt (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 60884522005710), received between Jun 28, 2018 and Apr 25, 2019 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (4 reports).
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
- Inflation Problem4
- Device Markings/Labelling Problem1
Patient problems
- No Patient Involvement4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
ACCORDING TO THE REPORTER, THE PIPE NUMBERING WAS DELETED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8551889 ↗MalfunctionJun 28, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, TWO TUBES FAILED TO INFLATE DURING PRE-CHECK TEST AND WERE DISCARDED. THE OTHER TWO WERE NOT USED AND WILL BE RETURNED FOR INVESTIGATION. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7645714 ↗MalfunctionJun 28, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, TWO TUBES FAILED TO INFLATE DURING PRE-CHECK TEST AND WERE DISCARDED. THE OTHER TWO WERE NOT USED AND WILL BE RETURNED FOR INVESTIGATION. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7645647 ↗MalfunctionJun 28, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, TWO TUBES FAILED TO INFLATE DURING PRE-CHECK TEST AND WERE DISCARDED. THE OTHER TWO WERE NOT USED AND WILL BE RETURNED FOR INVESTIGATION. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7645474 ↗MalfunctionJun 28, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, TWO TUBES FAILED TO INFLATE DURING PRE-CHECK TEST AND WERE DISCARDED. THE OTHER TWO WERE NOT USED AND WILL BE RETURNED FOR INVESTIGATION. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7645465 ↗
Other Tube, tracheal (w/wo connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 reports
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