Shiley 86397Recalls & reported problems
Covidien LP · Laser Oral Tracheal Tube Dual Cuffed Murphy Eye · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884522002059), received between Dec 12, 2018 and Jan 6, 2026 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Loose or Intermittent Connection1
- Manufacturing, Packaging or Shipping Problem1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Use of Device Problem; Defective Component
IT WAS REPORTED THAT DURING USE, IT WAS OBSERVED THAT THE ENDOTRACHEAL TUBE'S CUFF WAS TOO BULKY AND STIFF FOR A TUBE'S SIZE WHICH WAS DESIGNED FOR PEDIATRIC PATIENTS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974828 ↗MalfunctionApr 26, 2022Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn; Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE TRACHEAL TUBE WAS REMOVED FROM THE PACKAGING, THE DAMAGED CUFF WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14206430 ↗MalfunctionDec 12, 2018Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF PINHOLES. THERE WAS NO REPORTED PATIENT OUTCOME OR INJURY.
Patient problems: No Information
MAUDE report 8155368 ↗MalfunctionDec 12, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE DEVICE WAS NOT ABLE TO DISCONNECT FROM THE VENTILATOR¿S Y CONNECTION. THERE WAS NO REPORTED PATIENT OUTCOME OR INJURY.
Patient problems: No Information
MAUDE report 8155022 ↗
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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