The Recall Desk
SevereFDA (Devices)·Z-1440-2023·Announced 2023-05-24

Draeger VentStar Basic ventilator breathing circuit connections may detach during use

Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.

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 classification requires a minimum severity score of 4. This recall involves a critical ventilator component—breathing circuit connections—that can detach during patient use, potentially compromising ventilation delivery to patients dependent on the device.

Plain-English summary

Draeger Medical, Inc. is recalling 325 units of the VentStar Basic (P)180 ventilator, Model MP00351, distributed nationwide throughout the United States. All lots are affected, as identified by UDI-DI 04048675422068.

The glued connections of the breathing circuit can become loose before or during ventilation, potentially resulting in partial or complete detachment of circuit pieces. This disconnection could interfere with proper ventilation delivery.

Healthcare facilities and providers using this ventilator model are affected by this recall.

Affected facilities should immediately stop using the device and contact Draeger Medical, Inc. for repair or replacement options.

The recalled product

Product
VentStar Basic (P)180, MP00351
Manufacturer
Draeger Medical, Inc.
Hazard
  • circuit-disconnection
  • equipment-failure

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: 04048675422068
  • All lots.

Distribution

Distributed nationwide across the United States.