Mallinckrodt 85863Recalls & reported problems
Covidien LP · Intubating Stylet · Class 1
All models of Mallinckrodt (73)
Data updated Oct 16, 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 80884522004076), received between Feb 28, 2019 and Feb 28, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “False Alarm” (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 16, 2026.
Most reported problems
Device problems
- False Alarm1
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.
InjuryFeb 28, 2019False Alarm; False Alarm
ACCORDING TO THE REPORTER, THE DEVICE IS DEFECTIVE AND THE METAL PART DID NOT GO TO THE END THE UNIT. THIS WAS FOUND DURING A CODE AND THEY USED ANOTHER DEVICE ON THE PATIENT. ANOTHER DEVICE WAS USED ON THE PATIENT.
Patient problems: Extubate
MAUDE report 8380215 ↗
Other STYLET, TRACHEAL TUBE devices
- Shiley 85864Covidien LP · STYLET, TRACHEAL TUBE15 reports
- Shiley 85863Covidien LP · STYLET, TRACHEAL TUBE13 reports
- GlideRite® Single-Use Stylet – SmallVerathon Medical (Canada) ULC · Stylet, Tracheal Tube7 reports
- HUDSON RCI IPN048992Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- HUDSON RCI IPN044847Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- Shiley 85865Covidien LP · STYLET, TRACHEAL TUBE3 reports
- Mallinckrodt 85864Covidien LP · STYLET, TRACHEAL TUBE2 reports
- Vital Signs™ S5000NAirlife · STYLET, TRACHEAL TUBE2 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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