Shiley 86051Recalls & reported problems
Covidien LP · Lo-Pro Oral/Nasal Tracheal Tube Cuffed,Murphy Eye · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Shiley cuffed tracheal tube is reported in 77 adverse event reports; all describe malfunctions, with no deaths and no injuries. The reports mostly describe air leaks in the cuff and inflation problems, sometimes during patient intubation and requiring tube replacement. There is 1 open recall, started February 2023, due to potential leaks in the inflation system.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 20884522000243), received between Aug 28, 2018 and Jul 25, 2024 — classified as 77 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (48 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Feb 10, 2023Open, Classified
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Z-1318-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Gas/Air Leak48
- Material Split, Cut or Torn14
- Use of Device Problem10
- Defective Component3
- Inflation Problem3
- Contamination of Device Ingredient or Reagent2
- Crack2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Insufficient Information22
- Unintended Extubation11
- No Patient Involvement5
- No Consequences Or Impact To Patient2
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE WHEN AIR WAS INJECTED THROUGH THE PILOT BALLOON DURING TESTING. A DIFFERENT DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19829440 ↗MalfunctionApr 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE WAS FOUND LEAKING ONCE INSERTED INTO THE PATIENT. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19135707 ↗MalfunctionMar 18, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK ONCE IT WAS INSERTED IN THE PATIENT DURING SURGERY. THE REPLACEMENT OF THE TUBE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 18927307 ↗MalfunctionFeb 17, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WAS PRE-CHECK USING SYRINGE PRIOR TO INTUBATION AND SEEMS TO HAVE NO ISSUE. DURING USE ON PATIENT, THE CUFF HAD A SIGNIFICANT AIR LEAK AND UNABLE TO PROVIDE POSITIVE PRESSURE VENTILATION. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE OVER A BOUGIE. THE REPORTED DEVICE WAS EXAMINED AND NOTED THAT THERE WAS A LEAKING FROM THE INSIDE PORTION OF THE CUFF AND THE TUBE.
Patient problems: Unintended Extubation
MAUDE report 16398114 ↗MalfunctionFeb 6, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE BALLOON HAD A HOLE AND WOULD NOT HOLD AIR. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 16309330 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 16302134 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302073 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT INFLATE DURING INTUBATION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302067 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302065 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302061 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302054 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 16301939 ↗MalfunctionFeb 5, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PATIENT WAS INTUBATED, THE CUFF WOULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 16301938 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16218412 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217658 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217485 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217317 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217190 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16217011 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216589 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216445 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216387 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216346 ↗MalfunctionJan 20, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELEVEN DEVICES HAD LEAK AT THE BALLOON WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216297 ↗MalfunctionJan 6, 2023Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING AN EMERGENT RE-INTUBATION OF A THYROIDECTOMY PATIENT, THE EXTUBATION WAS DELAYED DUE TO A CUFF THAT CONTINUED TO RE-INFLATE. IT WAS UNABLE TO DETERMINE IF THERE WAS A LEAK AROUND THE CUFF AND THE PATIENT REMAINED INTUBATED FOR SEVERAL DAYS LONGER THAN NECESSARY. AFTER SUCCESSFUL EXTUBATION, THE ENDOTRACHEAL TUBE'S CUFF REFILLED WITH ATMOSPHERIC AIR WITHOUT BEING PRESSURIZED BY A SYRINGE OF AIR AT THE PILOT BALLOON AND WAS WITNESSED BY THREE OTHER PROVIDERS.
Patient problems: Unintended Extubation
MAUDE report 16117868 ↗
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 · each recall links to the FDA recall notice
- 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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