VentStar Watertrap breathing circuit connections may detach during ventilation
Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.
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 mandates a minimum severity score of 4. The defect—loose glued connections in breathing circuit components—could result in partial or complete detachment during patient ventilation, posing serious patient safety risk.
Plain-English summary
Draeger Medical, Inc. is recalling the VentStar Watertrap (N) 180 (model MP00363), a breathing circuit component used in ventilation systems. The FDA has classified this as a Class I recall.
The glued connections joining the breathing circuit components can become loose before or during ventilation, potentially resulting in partial or complete detachment of the pieces. A disconnected breathing circuit during patient ventilation presents a serious patient safety risk.
Approximately 125 units of this device were distributed nationwide in the United States. The recall affects all lots of the product, identified by UDI-DI: 04048675421993.
The recalled product
- Product
- VentStar Watertrap (N) 180, MP00363
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 125
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: 04048675421993
- 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
Similar recalls
- HighDraeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger VentStar Anesthesia Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- HighDräger VentStar Basic Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Medical Recalls ID Circuit Watertrap Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30