Volara Home Care Oxygen Systems May Fail to Provide Sufficient Oxygen and Could Cause Lung Damage, FDA Warns

Baxter and the FDA warn the systems could cause overexpansion of the lungs, leading to lung damage and oxygen deficiency.

Federal health officials indicate that certain Volara home care oxygen systems have the potential to malfunction, resulting in a lack of oxygen delivery and an increased risk of lung tissue damage for users.

The FDA issued the Volara home oxygen system warning on June 2, recommending patients to stop using the ventilators if they experience signs of respiratory distress, and to seek immediate medical attention if the symptoms do not subside.

To date, an official Volara oxygen system recall has not been issued, however the FDA been notified of one injury report of a patient experiencing oxygen desaturation while using the Volara device in a home care environment.

The Volara Systems are used for Oscillation and Lung Expansion (OLE) therapy and are designed to be used in the home setting to provide alternating cycles of Continuous Positive Expiratory Pressure (CPEP) and Continuous High Frequency Oscillation (CHFO), combined with aerosol delivery.

According to the warning, when the Volara system is used in line with a ventilator, the device can allow an overexpansion of the lungs that may result in oxygen desaturation, which is a condition that causes a dangerous decrease in oxygen levels. In this event, users could experience signs of respiratory distress including increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails and changes in alertness.

Following a report of a patient suffering oxygen desaturation after using the Valora System, Baxter International Inc. issued an Urgent Medical Device Correction on June 1, warning patients to immediately stop using the devices if they experience symptoms of respiratory distress.

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

The warning involves Volara System with model numbers PVL1HCBA, M08594, and M08594A with in-line ventilator adaptor (M07937 MODULE, OPTIMUS HANDSET 2) or Volara Patient Circuit Kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT that include M07937).

Baxter announced it will be releasing an update to the Instructions For Use (IFU) manual to help ensure correct usage of the device. Once the updated IFU is available, Baxter indicates it will contact patients to arrange for a trainer to conduct a home visit to provide additional training.

Customers with additional questions or concerns regarding their Volara systems are being encouraged to contact Hillrom Customer Service Support at 800-426-4224 or Baxter Product Surveillance at 800-437-5176.


"*" indicates required fields

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Suboxone Settlements Failed to Compensate Users Left With Tooth Decay or Tooth loss
Suboxone Settlements Failed to Compensate Users Left With Tooth Decay or Tooth loss (Posted today)

Although Suboxone settlements have been paid to resolve antitrust violations, users who suffered damages due to tooth decay from Suboxone film must pursue individual product liability lawsuits

Bard 3DMax Hernia Mesh Lawsuit Set for Trial To Begin in April 2024
Bard 3DMax Hernia Mesh Lawsuit Set for Trial To Begin in April 2024 (Posted yesterday)

With thousands of Bard hernia mesh lawsuits pending in the federal court system, a fourth bellwether trial will be held in the spring, involving allegations that defects with Bard 3DMax caused painful and permanent injuries.