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LIVVE™ Size 4.5

Wm & Dg, Inc. · Model LB1545 · UDI-DI 00850027063034

CAE Prescription

510(k) clearances

1,590

Adverse events (39 deaths)

Recalls

231

Facilities

Description

The LIVVE™ (Laryngeal, Intubating, Visualizing, Ventilating, and Extubating Device) is a single-use, non-sterile, 2-lumen channel device with a cushioned cuff to ensure a semi-closed ventilation system is maintained during ventilation and oral intubation. Adult size 4.5: > 90 kg (198 lbs)

Recalls

Date	Firm	Reason
2026-07-07	INTEGRATED MEDCRAFT LLC	Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
2026-06-15	Intersurgical Inc	Devices could potentially be occluded or partially occluded.
2026-06-15	Intersurgical Inc	Devices could potentially be occluded or partially occluded.
2025-06-20	Intersurgical Inc	Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf
2025-06-20	Intersurgical Inc	Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf
2024-09-26	King Systems Corp. dba Ambu, Inc.	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
2024-09-26	King Systems Corp. dba Ambu, Inc.	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
2024-09-26	King Systems Corp. dba Ambu, Inc.	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
2024-09-26	King Systems Corp. dba Ambu, Inc.	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
2024-09-26	King Systems Corp. dba Ambu, Inc.	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.