LMA AIRWAY MANAGEMENT IPN924148Recalls & reported problems
Teleflex Incorporated · LMA® Unique™ (Silicone Cuff) Airway with Pilot Balloon Size 4 · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15060112319362), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Erythema1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT: " I HAVE TAKEN CARE OF A 15 YEAR OLD BOY TWICE, BOTH TIMES USING AN LMA FOR UNDER AN HOUR. ON BOTH OCCASIONS THE PATIENT COMPLAINED OF SIGNIFICANT THROAT PAIN FOR SEVERAL DAYS POST OPERATIVELY. BASED ON HIS FIRST EXPERIENCE, THE SECOND TIME I CARED FOR HIM I SIZED DOWN TO A '3, UNDERINFLATED THE CUFF, LUBRICATED GENEROUSLY AND NEITHER TIME WAS THERE ANY DIFFICULTY IN PLACING THE LMA OR BLOOD ON IT WHEN REMOVED TO INDICATE ANY TRAUMA. HE HAS LOST 6 LBS SINCE SURGERY AS HE IS UNABLE TO SWALLOW." PHOTO SHOWS ERYTHEMA AT THE BACK OF THE THROAT. ADDITIONAL INFORMATION: "THE PATIENT IS A 15 YR OLD MALE, 5' 7" 150 LBS NO SIGNIFICANT MEDICAL HISTORY. I REFERRED THE PATIENT TO AN ENT FOR EVALUATION ON POST OP DAY 6. THE ENT PLACED THE PATIENT ON A COURSE OF STEROIDS AND PAIN MEDICATION. IT IS NOW ONE WEEK AFTER TREATMENTS INITIATED BY THE ENT AND PATIENT'S THROAT PAIN HAS RESOLVED."
Patient problems: Erythema; Pain
MAUDE report 20924811 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
- GUEDEL AIRWAY, SIZE 2, ISO 8 1112080Intersurgical Incorporated · 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 KLTSD422King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- GUEDEL AIRWAY, SIZE 000, ISO 3.5 1000035Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- Medline DYND300020PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300025PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300010PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.