The Recall Desk
SevereFDA (Devices)·Z-1455-2023·Announced 2023-05-24

Ventstar Coax 180 Ventilator Breathing Circuit Connections May Detach

Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall for critical life-support ventilation equipment where breathing circuit connections can detach. Per the severity rubric, FDA Class I recalls score no lower than 4 (Severe). No illnesses or deaths have been reported.

Plain-English summary

Draeger Medical, Inc. is recalling 18,160 units of the Ventstar Coax 180 ventilator (model MP03374) distributed nationwide in the United States.

The breathing circuit of this ventilator uses glued connections that can become loose before or during ventilation. When this occurs, pieces may partially or completely detach from the breathing circuit.

This recall affects patients and healthcare facilities using the Ventstar Coax 180 ventilator. Healthcare providers should immediately review the status of this equipment and contact Draeger Medical for instructions.

Patients and healthcare workers should discontinue use if any loose or compromised connections are detected on the breathing circuit.

The recalled product

Product
Ventstar Coax 180, MP03374
Manufacturer
Draeger Medical, Inc.
Hazard
  • breathing-circuit-detachment
  • connection-failure

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: 04048675545576
  • All lots.

Distribution

Distributed nationwide across the United States.