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.
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 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
- Affected units
- 1,725
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.
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 →Related recalls
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