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.
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: 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.
- Category
- Medical Device — Ventilator
- Affected units
- 18,160
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.
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
Same manufacturer · Draeger Medical, Inc.
See all →- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- SevereDräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
FDA (Devices) · 2024-04-24
Same hazard · breathing circuit detachment
See all →- SevereAnesthesia Ventilator Breathing Circuit Connections May Detach During Use
FDA (Devices) · 2023-05-24
- SevereVentstar Coax breathing circuit connections recalled for loose glued joints
FDA (Devices) · 2023-05-24
- SevereBreathing circuit component connections may become loose during ventilation
FDA (Devices) · 2023-05-24
- SevereVentStar Watertrap Breathing Circuit Connections May Detach During Use
FDA (Devices) · 2023-05-24
Similar recalls
- HighDräger VentStar Basic Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger VentStar Anesthesia Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Medical Recalls VentStar Basic 180 Breathing Circuits
FDA (Devices) · 2019-01-30
- HighDraeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30