Mallinckrodt 86551Recalls & reported problems
Covidien LP · Oral/Nasal Tracheal Tube Cuffed,Reinforced, Murphy Eye · Class 2
All models of Mallinckrodt (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884522043366), received between Jun 28, 2017 and Nov 4, 2020 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 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 16, 2026.
Most reported problems
Device problems
- Defective Component2
- Air Leak1
- Burst Container or Vessel1
- Material Deformation1
Patient problems
- Extubate2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2020Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A NARROW CANNULA TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10785414 ↗InjuryOct 4, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT RETURN TO SHAPE WHEN BITTEN DOWN AND FOUND OUT TO HAVE A WIRE EXPOSURE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.
Patient problems: Extubate
MAUDE report 9154547 ↗MalfunctionJun 28, 2019Material Deformation; Material Deformation
ACCORDING TO THE REPORTER, THE DEVICE'S TUBE HAD DEFORMED TIP MAKING IT IMPOSSIBLE TO USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746321 ↗InjuryNov 8, 2018Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE REPORTER, THERE WAS LEAKAGE INSIDE THE ENDOTRACHEAL TUBE. THE PATIENT WAS RE-INTUBATED.
Patient problems: Extubate
MAUDE report 8051106 ↗MalfunctionJun 28, 2017Air Leak; Air Leak
MEDTRONIC RECEIVED A REPORT THE TRACHEAL TUBE'S BALLOON WAS BROKEN/DAMAGED. CUSTOMER INDICATED THERE WAS NO PATIENT INJURY WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675684 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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