The Recall Desk
SevereFDA (Devices)·Z-1448-2023·Announced 2023-05-24

VentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment

Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.

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: This is an FDA Class I recall, which per classification rules cannot score below 4. Although no deaths, serious injuries, or illnesses have been reported, the defect affects a critical life-support device where breathing circuit disconnection could compromise patient ventilation.

Plain-English summary

Draeger Medical, Inc. has recalled 1,725 units of the VentStar Basic (N) 180 ventilator (model MP00353) due to a defect in the breathing circuit connections.

The glued connections that secure the breathing circuit components can become loose before or during ventilation. This can result in partial or complete detachment of pieces of the breathing circuit.

When breathing circuit components detach, ventilation delivery may be disrupted. This poses a risk to patients who depend on the device for breathing support. The product is distributed throughout the United States.

The recalled product

Product
VentStar Basic (N) 180, MP00353
Manufacturer
Draeger Medical, Inc.
Category
Medical Device — Ventilator
Hazard
  • circuit-disconnection
  • 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: 40048675422044
  • All lots.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category