Frequently Asked Questions
What is a consent decree?
A consent decree is a negotiated agreement between Invacare and the FDA that is filed with the US District Court. For Invacare, the consent decree limits manufacturing and distribution of custom wheelchairs at our Taylor Street facility, and the design of wheelchairs and power beds at our corporate facility until the affected quality systems and processes are certified as compliant with FDA regulations.
What were the FDA's observations that led Invacare to enter into a consent decree?
The FDA regulates all aspects of medical device companies, from when we design and engineer new devices, through manufacturing and distribution.
Invacare has always had quality control systems and processes in place, however, the FDA made inspectional observations at Invacare's Taylor Street and corporate facilities in Elyria, Ohio regarding areas we needed to improve to bring them into compliance with the Quality System Regulation. We've been working on those improvements for more than a year, and we will continue to work every day until the FDA notifies Invacare that the facilities are compliant.
How long will normal operations be suspended?
There are specific steps that Invacare has to take to resume operations at its Taylor Street manufacturing facility (Link to press Release). However, we cannot speculate as to how long it will take to complete the audits and resume full operations. We're committed to full compliance with FDA regulations, and we intend to work cooperatively with the FDA to resolve their concerns as quickly as possible. All other Invacare manufacturing operations remain in full production.
Has the FDA raised specific quality or safety concerns in its observations?
No. The FDA did not raise a specific product safety concern in the consent decree. Invacare has a 30-year history of making life's experiences possible for the people who rely on our products. We've always taken patient safety and product quality very seriously. We rigorously test our products to ensure their quality and safety, and we stand behind every product we make when they are used as directed.
Did the FDA require Invacare to perform product recalls?
What products will be impacted?
The limitations on manufacturing only apply to the power and manual wheelchairs, wheelchair components and wheelchair sub-assemblies that are produced at Invacare's Taylor Street manufacturing facility. The consent decree has important exceptions which permit production of many of these products under specific circumstances and with the appropriate documentation. A complete list is located on the notification guide.
All other Invacare facilities outside of Taylor Street remain in full production.
Who can I contact with questions about how the consent decree impacts me?
Please contact your Invacare sales representative or call customer service at 1-800-333-6900.