Curaplex 477-KLTSD4125Recalls & reported problems
Bound Tree Medical, LLC · Curaplex Supraglottic Airway Kit, King LTS-D, Size 2.5, 25-35 kg · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817617020549), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Product Quality Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2020Product Quality Problem; Manufacturing, Packaging or Shipping Problem
CURAPLEX SUPRAGLOTIC AIRWAY KIT, KING LTS-D, SIZE 2.5, 25-35KG #477-KLTSD4125 (LOT #ASM0021574) CONTAINS: (1) SUPRAGLOTIC AIRWAY, KING LTS-D SIZE 2.5 (1) SYRINGE ONLY, 10 OC LUER LOCK (1) GASTRIC TUBE, 16FR (1) PACKET OF LUBRICATING JELLY. THE MANUFACTURER (AMBU) OF THE KING AIRWAY LTS-D RECOMMENDS AN INFLATION VOLUME OF 30-40 CC FOR THE DEVICE AND THE PACKAGED PRODUCT FROM THE MANUFACTURER COMES WITH A SYRINGE SIZED TO SUPPORT THIS VOLUME. THE 10 CC SYRINGE FOUND IN THE CURAPLEX KIT WITH THE SAME KING AIRWAY DEVICE COULD RESULT IN AN UNDER-INFLATED BALLOON IF THE USER DOES NOT RE-LOAD THE SYRINGE WITH AIR 3-4 TIMES. AN UNDER-INFLATED BALLOON COULD LEAD TO DEVICE FAILURE RESULTING IN HYPOXIA AND IF UNTREATED DEATH. CURAPLEX PRODUCT BY SAMOVA HC. LLC'S FAMILY OF COMPANIES: BOUND TREE MEDICAL LLC. CARDIC PARTNERS, INC. EMERGENCY MEDICAL PRODUCTS, INC. & TRI-ANIM HEALTH SERVICES INC. DISTRIBUTOR: (B)(4). FDA SAFETY REPORT ID # (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9774578 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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