LMA AIRWAY MANAGEMENT IPN922891Recalls & reported problems
Teleflex Incorporated · LMA ProSeal™ Size 4 · 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 15060112318730), received between Nov 23, 2022 and Feb 14, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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
- Manufacturing, Packaging or Shipping Problem3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2023Break; Break
REPORTED EVENT: 15MM CONNECTOR OF LMA PROSEAL #4 SNAPPED OFF WHEN THE DOCTOR TRIED TO CONNECT TO CIRCUIT WITHOUT MUCH FORCE. THE DEVICE WAS USED ONLY 20 TIMES. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16373540 ↗MalfunctionNov 23, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT "THE RED CAP OF THE MANUAL VENT IS MISSING" WHILE IN USE ON PATIENT. FURTHER INFORMATION STATES THAT THERE WERE NO ISSUES WITH DEFLATION/INFLATION OF THE CUFF DURING USE AND THAT THIS WAS A RE-STERILIZED DEVICE. AN INFLATION/DEFLATION TEST OCCURRED PRIOR TO USE HOWEVER THE MISSING CAP WAS NOT NOTED. PATIENT STATUS REPORTED AS "FINE". ASSOCIATED MDRS: 9681900-2022-00031 AND 9681900-2022-00033.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15852675 ↗MalfunctionNov 23, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT "THE RED CAP OF THE MANUAL VENT IS MISSING" WHILE IN USE ON PATIENT. FURTHER INFORMATION STATES THAT THERE WERE NO ISSUES WITH DEFLATION/INFLATION OF THE CUFF DURING USE AND THAT THIS WAS A RE-STERILIZED DEVICE. AN INFLATION/DEFLATION TEST OCCURRED PRIOR TO USE HOWEVER THE MISSING CAP WAS NOT NOTED. PATIENT STATUS REPORTED AS "FINE". SEE ASSOCIATED MDRS 9681900-2022-00032 AND 9681900-2022-00033.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15852634 ↗MalfunctionNov 23, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT "THE RED CAP OF THE MANUAL VENT IS MISSING" WHILE IN USE ON PATIENT. FURTHER INFORMATION STATES THAT THERE WERE NO ISSUES WITH DEFLATION/INFLATION OF THE CUFF DURING USE AND THAT THIS WAS A RE-STERILIZED DEVICE. AN INFLATION/DEFLATION TEST OCCURRED PRIOR TO USE HOWEVER THE MISSING CAP WAS NOT NOTED. PATIENT STATUS REPORTED AS "FINE". SEE ASSOCIATED MDRS 9681900-2022-00031 AND 9681900-2022-00032.
Patient problems: Insufficient Information
MAUDE report 15852542 ↗
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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