LMA AIRWAY MANAGEMENT IPN922773Recalls & reported problems
Teleflex Incorporated · LMA® Unique™ (Silicone Cuff) Cuff Pilot™ Size 5 · Class 1
All models of LMA AIRWAY MANAGEMENT (47)
Data updated Oct 18, 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 15060112318198), received between Nov 2, 2021 and Jan 3, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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 18, 2026.
Most reported problems
Device problems
- Deflation Problem2
- Device Markings/Labelling Problem2
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2023Deflation Problem; Deflation Problem
REPORTED ISSUE: THE CUFF STAYED IN THE RED ZONE WHEN INFLATED THEN IT WAS UNABLE TO BE INFLATED OR DEFLATED WITH SYRINGE. THE DEFECT WAS DETECTED JUST BEFORE INSERTION INTO THE PATIENT. THE INTERVENTION WAS TO GRAB ANOTHER ONE AND KEEP BAGGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16085635 ↗MalfunctionDec 20, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
REPORTED ISSUE: THE CUFF STAYED IN THE RED ZONE WHEN INFLATED THEN IT WAS UNABLE TO BE INFLATED OR DEFLATED WITH SYRINGE. THE DEFECT WAS DETECTED JUST BEFORE INSERTION INTO THE PATIENT. THE INTERVENTION WAS TO GRAB ANOTHER ONE AND KEEP BAGGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018182 ↗MalfunctionNov 2, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED, "THE MARKINGS ARE COMING OFF. DURING INTUBATION". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12737893 ↗MalfunctionNov 2, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED "THE MARKINGS ARE COMING OFF DURING INTUBATION". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12737826 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
- Air-Q3® 50005Airlife · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- King LTS-D KLTSD420King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300015PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- KING LTS-D Kit KLTSD430King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300040PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- King LTS-D KLTSD421King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- ONE-PIECE GUEDEL AIRWAY, SIZE 3, ISO 9 1113090Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- KING LTS-D Kit KLTSD432King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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