Ventilator Correction: Baxter Updates Use Instructions For Volara Single-patient Use Circuits
Baxter is updating instructions for Volara Single-Patient Use Circuits because using them in-line with a ventilator in a home setting could cause oxygen desaturation (low blood oxygen levels) or barotrauma (lung injury from pressure changes). The update clarifies how the device should be used safely with ventilators in home environments. This correction affects patients using Volara circuits with ventilators at home.
- Product
- Volara Single-Patient Use Circuits
- Reason
- When the Volara system is used in a home setting, there is a risk for oxygen desaturation or barotrauma if it is used in-line with a ventilator.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-04-09
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/27849022-3d24-405e-9695-bc8368fa7f52