The Recall Desk
SevereFDA (Devices)·Z-1449-2023·Announced 2023-05-24

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.

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: 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.
Category
Medical Device — Breathing Circuit / Ventilator Component
Hazard
  • breathing-circuit-disconnect
  • equipment-malfunction

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.

Related recalls

Same category