Ventstar Coax breathing circuit connections recalled for loose glued joints
Draeger Medical recalls 2,380 Ventstar Coax breathing circuits due to glued connections that can become loose or detach during ventilation.
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: FDA Class I medical device recall. The agency's own Class I classification establishes a minimum severity score of 4 per the rubric, applied to critical ventilator components with structural failure potential.
Plain-English summary
Draeger Medical, Inc. is recalling 2,380 units of the Ventstar Coax breathing circuit (model MP03373) distributed nationwide due to structural integrity issues with glued connections.
Glued connections on the breathing circuit can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces. This poses a risk to patients dependent on mechanical ventilation.
All lots of the affected device are identified by UDI-DI 04048675545552. Healthcare facilities and clinicians using this device should discontinue use and contact Draeger Medical for replacement or further instructions.
The recalled product
- Product
- Ventstar Coax, MP03373
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 2,380
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: 04048675545552
- 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 →- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
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
- 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
- SevereVentstar Coax 180 Ventilator Breathing Circuit Connections May Detach
FDA (Devices) · 2023-05-24