Agency classClass IOur severity:Severe FDA (Devices)·Z-1443-2023·Announced 2023-05-24

Draeger VentStar Watertrap breathing circuit glued connections may loosen during ventilation

Glued connections on the VentStar Watertrap breathing circuit can become loose or detach during ventilation, potentially interrupting airflow. Draeger Medical is recalling all affected units nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4. The hazard—potential detachment of breathing circuit connections during ventilation—could interrupt airflow to patients dependent on mechanical ventilation, representing a serious health risk.

Plain-English summary

Draeger Medical, Inc. is recalling the VentStar Watertrap (P) 180 breathing circuit component (Model MP00362) due to a defect in the glued connections.

The glued connections of the breathing circuit can become loose before or during ventilation, resulting in partial or complete detachment of pieces. If the connections become detached while a patient is receiving mechanical ventilation, airflow to the patient could be interrupted.

The product was distributed nationally throughout the United States. All lots of this device are affected by this recall.

Patients, caregivers, and healthcare providers using this device should immediately stop use and contact Draeger Medical, Inc. for return or replacement instructions. Any adverse events or injuries related to use of this device should be reported to the FDA through MedWatch.

The recalled product

Product: VentStar Watertrap (P) 180 w/oLL, MP00362
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Respiratory
Hazard: breathing-circuit-disconnection
connection-failure
Affected units: 25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI-DI: 04048675422006
All lots.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →

Same manufacturer · Draeger Medical, Inc.

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