Mallinckrodt 85864Recalls & reported problems
Covidien LP · Intubating Stylet · Class 1
All models of Mallinckrodt (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 80884522004083), received between Jul 11, 2017 and Aug 8, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Device Markings/Labelling Problem1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2017Defective Component; Defective Component
MEDTRONIC RECEIVED A REPORT THAT THE UNIT WAS HAVING A LABELING ISSUE. IT WAS INCORRECT. THE ISSUE WAS DETECTED IN THE DISTRIBUTION CENTER, THEREFORE, THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE CUSTOMER DISCARDED THE PRODUCT.
Patient problems: No Patient Involvement
MAUDE report 6774831 ↗MalfunctionJul 11, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem
MEDTRONIC RECEIVED A REPORT THAT 380 UNITS OF LOT 16K0104JZX HAD A LABELING ISSUE. THE REPORTER STATED THAT THE VALIDITY DATE IS DIVERGENT BETWEEN THE PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 6704837 ↗
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 IPN044847Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- HUDSON RCI IPN048992Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- Shiley 85865Covidien LP · STYLET, TRACHEAL TUBE3 reports
- Vital Signs™ S5000NAirlife · STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 85865Covidien LP · STYLET, TRACHEAL TUBE1 report
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