Philips Respironics Recalls Certain Trilogy EVO Ventilators For Potential Health Risks From PE-PUR Foam
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 Products & Model Numbers
- Trilogy Evo ventilator model numbers with certain serial numbers as listed in the recall database:
- KR2110X15B (not distributed in the U.S.)
- Repair kits for Trilogy Evo muffler assembly model and lot numbers as listed in the recall database:
- Part number 1135257
- Lot numbers between 210414 and 210524
- Manufacturing Dates: April 15, 2021 to May 24, 2021
- Distribution Dates: April 15, 2021 to May 24, 2021
- Devices Recalled In The U.S.: 215 Trilogy Evo ventilators; 51 Trilogy Evo repair kits
- Date Initiated By Firm: December 21, 2021
NOTE: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. Certain other Trilogy models are NOT AFFECTED by this issue and are NOT SUBJECT TO THE RECALL: Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal.
Reason For The Recall
Philips Respironics has recalled certain Trilogy Evo ventilators with specific serial numbers due to potential health risks. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material, in the muffler assembly of the affected Trilogy Evo ventilators. The issue was identified during lab testing of the Trilogy Evo ventilator. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. There have been no reported injuries or death to date.
The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
For more information, please see the Potential Health Risks from Sound Abatement Foam section of the Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.
Who May Be Affected
- People using these devices and their caregivers
- Health care providers and facilities
- Durable Medical Equipment (“DME”) suppliers
What To Do
Philips Respironics sent an Urgent Medical Device Recall notification to Trilogy Evo ventilator customers on December 21, 2021, and the company sent an updated version to clarify information on cleaning and filters on January 13, 2022.
The notification requested customers take the following actions:
- Create awareness of this safety information by forwarding to your organization’s personnel.
- Identify all of the impacted devices purchased by your organization.
- Do not stop or change patient therapy unless the patient has consulted their health care provider or unless a replacement Trilogy Evo ventilator has been provided.
- Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. Using an inline bacterial filter may help to filter out particles of foam. Additionally, after placement of an inline filter, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance and monitor as ventilator performance may change due to increase in resistance of air flow through the device after filter placement. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
- Inspect and clean the patient circuit and accessories per the instructions included with the notification.
- A replacement Trilogy Evo ventilator will be provided by Philips. Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. The packing instructions are in Appendix A of the notification.
For the repair kit for Trilogy Evo muffler assembly, the December 21, 2021 notification letter requested customers take the following actions:
- Segregate inventory of Repair Kit – Trilogy Evo Muffler Assembly Part Number 1135257, and quarantine any lot between 210414 and 210524.
- Do not use any quarantined material and contact Philips for return instructions. You will be shipped replacements.
- Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later
- If the lot number used in repair is between 210414 and 210524. Contact Philips for next steps. Philips will replace the device these parts were installed into.
- If the lot number used in a repair is unknown, assume it is affected and contact Philips for next steps. Philips will replace the device these parts were installed into.
- If lot number is known and is not an affected lot, no further action is required.
For more information, please see the Recommendations section of the Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.
Contact Information, Full List Of Affected Devices & Additional Resources
Customers in the U.S. with questions about this recall should contact Philips Respironics at (800) 722-9377 or email [email protected].
A complete list of affected devices is available in the Medical Device Recalls database.
- Medical Device Recall Database Entries:
Source: U.S. Food & Drug Administration (Philips Respironics Recalls Certain Trilogy EVO Ventilators For Potential Health Risks From PE-PUR Foam).
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