Invacare Corporation Receives FDA Acceptance of First Certification Audit Related to Consent Decree

  Invacare Corporation Receives FDA Acceptance of First Certification Audit
  Related to Consent Decree

Business Wire

ELYRIA, Ohio -- May 13, 2013

Invacare Corporation (NYSE: IVC) today announced that the United States Food
and Drug Administration (FDA) has found acceptable the Company’s first
certification audit relating to the qualification and validation documentation
for equipment and processes at the Taylor Street manufacturing facility in
Elyria, Ohio. This acceptance permits the Company’s Taylor Street facility,
which is currently subject to limitations on production due to an FDA consent
decree, to resume manufacturing and distributing parts, components,
accessories and subassemblies to Invacare facilities other than the Taylor
Street or Corporate facilities, for further manufacturing or to provide
service related to medical devices manufactured at those other Invacare
facilities.

''This is an important step forward for the Company in demonstrating its
quality systems compliance to the FDA,'' said Gerald B. Blouch, president and
chief executive officer. ''I am incredibly proud of the Invacare team and all
of the work that they have put into improving our quality systems. This is the
first critical step in resuming full production at the Taylor Street
manufacturing facility.''

Of the two remaining certification audits, the second audit relating to the
Company’s design control systems is currently being reviewed by the FDA. Once
it receives the FDA's approval on the second certification report, the Company
may resume design activities, which will enable it to refocus its engineering
resources on new product development. The final, most comprehensive
third-party certification audit is a comprehensive review of the Company's
compliance with the FDA's Quality System Regulation at the impacted Elyria
facilities. That audit is well underway. After the certification report
relating to that audit is submitted to the FDA, the agency will conduct its
own inspection of the facility. Once the Company receives written notification
from the FDA that the Corporate and Taylor Street facilities appear to be in
compliance, the Company may resume full operations at those facilities.

Invacare Corporation (NYSE:IVC), headquartered in Elyria, Ohio, is the global
leader in the manufacture and distribution of innovative home and long-term
care medical products that promote recovery and active lifestyles.The Company
has 5,800 associates and markets its products in approximately 80 countries
around the world. For more information about the Company and its products,
visit Invacare's website at www.invacare.com.

This press release contains forward-looking statements within the meaning of
the ''Safe Harbor'' provisions of the Private Securities Litigation Reform Act
of 1995. Terms such as ''will,'' ''should,'' ''could,'' ''plan,'' ''intend,''
''expect,'' ''continue,'' ''believe'' and ''anticipate,'' as well as similar
comments, are forward-looking in nature that are subject to inherent
uncertainties that are difficult to predict. Actual results and events may
differ significantly from those expressed or anticipated as a result of risks
and uncertainties, which include, but are not limited to, the following:
compliance costs, limitations on the design, production and/or distribution of
Invacare's products, inability to bid on or win certain contracts, or other
adverse effects of the FDA consent decree of injunction; unexpected
circumstances or developments that might delay or adversely impact the results
of the third-party expert certification audits or FDA inspections of
Invacare's quality systems at the Elyria, Ohio, facilities impacted by the FDA
consent decree, including any possible requirement to perform additional
remediation activities; the failure or refusal of customers or healthcare
professionals to sign VMN or other certification forms required by the
exceptions to the consent decree; possible adverse effects of being leveraged,
including interest rate or event of default risks, including those relating
the company's financial covenants under its credit facility (particularly as
might result from the impacts associated with the FDA consent decree);
Invacare's inability to satisfy its liquidity needs, or additional costs to do
so; adverse changes in government and other third-party payor reimbursement
levels and practices both in the U.S. and in other countries (such as, for
example, more extensive pre-payment reviews and post-payment audits by payors,
or the Medicare national competitive bidding program covering nine
metropolitan statistical areas that started in 2011 and an additional 91
metropolitan statistical areas beginning in July 2013), impacts of the U.S.
Affordable Care Act that was enacted in 2010 (such as, for example, the
expected annual impact on Invacare of the excise tax beginning in 2013 on
certain medical devices and Invacare's ability to successfully offset such
impact); legal actions, regulatory proceedings or Invacare's failure to comply
with regulatory requirements or receive regulatory clearance or approval for
Invacare's products or operations in the United States or abroad; product
liability claims; exchange rate or tax rate fluctuations; inability to design,
manufacture, distribute and achieve market acceptance of new products with
greater functionality or lower costs or new product platforms that deliver the
anticipated benefits of the Company's globalization strategy; consolidation of
health care providers; lower cost imports; uncollectible accounts receivable;
difficulties in implementing/upgrading Enterprise Resource Planning systems;
risks inherent in managing and operating businesses in many different foreign
jurisdictions; ineffective cost reduction and restructuring efforts; potential
product recalls; decreased availability or increased costs of materials which
could increase the Company's costs of producing or acquiring the Company's
products, including possible increases in commodity costs or freight costs;
heightened vulnerability to a hostile takeover attempt arising from depressed
market prices for Company shares; provisions of Ohio law or in the Company's
debt agreements, shareholder rights plan or charter documents that may prevent
or delay a change in control, as well as the risks described from time to time
in Invacare's reports as filed with the Securities and Exchange Commission.
Except to the extent required by law, the Company does not undertake and
specifically decline any obligation to review or update any forward-looking
statements or to publicly announce the results of any revisions to any of such
statements to reflect future events or developments or otherwise.

Contact:

Invacare Corporation
Lara Mahoney, 440-329-6393
 
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