Anesthesia Ventilator Breathing Circuit Connections May Detach During Use
Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.
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 FDA Class I recall involves a structural defect in a critical anesthesia delivery device. Although no illnesses or injuries have been reported, the potential for serious patient harm from improper anesthesia delivery during surgery warrants the Class I designation and minimum score of 4.
Plain-English summary
Draeger Medical, Inc. is recalling 130 units of the VentStar Anesthesia WT (P)180, MP00374 anesthesia ventilator distributed nationwide in the United States.
The ventilators contain a defect in which glued connections of the breathing circuit can become loose before or during ventilation, resulting in partial or complete detachment of circuit components.
A loose or detached breathing circuit connection could impair or prevent the delivery of anesthesia during surgical procedures. This creates a risk of serious patient harm.
Healthcare facilities using this device should discontinue use and contact Draeger Medical, Inc. for repair, replacement, or return instructions.
The recalled product
- Product
- VentStar Anesthesia WT (P)180, MP00374
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 130
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: 04048675421948
- 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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Similar recalls
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