Volara System Recall
The Law Offices of Gregory Krasovsky is evaluating prospective legal claims from patients who have been injured by the Volara System by Baxter.
If you or someone you know has been using or may have been injured by the Volara System, then please contact our Law Offices ASAP so that we can review your potential claim.
The injured patient may be eligible for compensation.
- a product liability claim against the manufacturer of the Volara System
or
- a medical malpractice claim against the medical care provider(s) who prescribed, installed, maintained and/or monitored the medical device
then we could represent you on a contingency fee (success fee basis), which means we would collect our attorneys' fees only from compensation obtained for you from the defendant(s).
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Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
Product Name: Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit)
Product Model Numbers: PVLIHCBA, M08594, M08594A
Devices Recalled in the U.S.: 268
Dates distributed: May 28, 2020, to April 19, 2022
Date Initiated by Firm: April 26, 2022
Device Use
The Volara system is intended to help people clear mucus out of their airways, expand the lungs, and to treat or prevent a partial collapsed lung (pulmonary atelectasis). The system’s in-line ventilator adaptor component makes it possible for it to be used together with a ventilator (in-line) in home-care settings.
Reason for Recall
Baxter Healthcare Corporation, and its subsidiary company Hillrom, are recalling the Volara system because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The risks to affected patients include:
Choking on mucus or other airway secretions
An infection in the lungs (pneumonia) that prevents oxygen from getting to the blood (respiratory failure)
Brain injury caused by lack of oxygen to the brain (hypoxia)
Death
The risk of serious injury or death is more significant in home-care settings if the caregivers are not trained properly, the device is not connected properly, or if the caregiver is not prepared to address any issues that may arise caused by use of this device.
There has been one complaint and one injury, as well as two deaths, associated with the use of this device.
Who May Be Affected
Health care personnel who recommend use of the Volara system with in-line ventilator adaptor for patients on ventilators in a home-care setting.
Caregivers who oversee care of a patient who uses the Volara system with in-line ventilator adaptor in a home-care setting.
People who use a ventilator with the Volara system’s ventilator adaptor in a home-care setting.
https://www.fda.gov/medical-
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
Product Name: Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit)
Product Model Numbers: PVLIHCBA, M08594, M08594A
Devices Recalled in the U.S.: 268
Dates distributed: May 28, 2020, to April 19, 2022
Date Initiated by Firm: April 26, 2022
Device Use
The Volara system is intended to help people clear mucus out of their airways, expand the lungs, and to treat or prevent a partial collapsed lung (pulmonary atelectasis). The system’s in-line ventilator adaptor component makes it possible for it to be used together with a ventilator (in-line) in home-care settings.
Reason for Recall
Baxter Healthcare Corporation, and its subsidiary company Hillrom, are recalling the Volara system because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The risks to affected patients include:
Choking on mucus or other airway secretions
An infection in the lungs (pneumonia) that prevents oxygen from getting to the blood (respiratory failure)
Brain injury caused by lack of oxygen to the brain (hypoxia)
Death
The risk of serious injury or death is more significant in home-care settings if the caregivers are not trained properly, the device is not connected properly, or if the caregiver is not prepared to address any issues that may arise caused by use of this device.
There has been one complaint and one injury, as well as two deaths, associated with the use of this device.
Who May Be Affected
Health care personnel who recommend use of the Volara system with in-line ventilator adaptor for patients on ventilators in a home-care setting.
Caregivers who oversee care of a patient who uses the Volara system with in-line ventilator adaptor in a home-care setting.
People who use a ventilator with the Volara system’s ventilator adaptor in a home-care setting.
https://www.fda.gov/medical-
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COMPANY ANNOUNCEMENT
Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Summary
Company Announcement Date:
June 01, 2022
FDA Publish Date:
June 02, 2022
Product Type:
Medical Devices
Reason for Announcement:
Possible risk of oxygen desaturation
Company Name:
Baxter International Inc.
Brand Name:
Volara
Product Description:
Volara System (home care)
Company Announcement
Deerfield, Ill. – 2022-06-01 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment. These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion (OLE) therapy. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021.
As described in the Urgent Medical Device Correction, current patients should continue to use their Volara therapy as prescribed by their physician. Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator. Caregivers and/or patients who observe signs of respiratory distress should stop the Volara therapy immediately. If patients do not see improvement after stopping the Volara therapy, they should seek medical attention. Baxter received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.
In addition, Baxter will mitigate this risk by updating the Instructions For Use (IFU) manual to help ensure correct usage of the device. Once the updated IFU is available, Baxter will contact patients to arrange for a trainer to conduct a home visit to provide additional training. Baxter will also issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue.
This Urgent Medical Device Correction applies to Volara System 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).
The Volara System is distributed in the United States.
Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.
https://www.fda.gov/safety/
Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Summary
Company Announcement Date:
June 01, 2022
FDA Publish Date:
June 02, 2022
Product Type:
Medical Devices
Reason for Announcement:
Possible risk of oxygen desaturation
Company Name:
Baxter International Inc.
Brand Name:
Volara
Product Description:
Volara System (home care)
Company Announcement
Deerfield, Ill. – 2022-06-01 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment. These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion (OLE) therapy. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021.
As described in the Urgent Medical Device Correction, current patients should continue to use their Volara therapy as prescribed by their physician. Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator. Caregivers and/or patients who observe signs of respiratory distress should stop the Volara therapy immediately. If patients do not see improvement after stopping the Volara therapy, they should seek medical attention. Baxter received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.
In addition, Baxter will mitigate this risk by updating the Instructions For Use (IFU) manual to help ensure correct usage of the device. Once the updated IFU is available, Baxter will contact patients to arrange for a trainer to conduct a home visit to provide additional training. Baxter will also issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue.
This Urgent Medical Device Correction applies to Volara System 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).
The Volara System is distributed in the United States.
Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.
https://www.fda.gov/safety/