ALAMEDA, Calif., Dec. 15, 2020 /PRNewswire/ -- Penumbra, Inc.
(NYSE: PEN) today announced that it is voluntarily recalling all
configurations of the Penumbra JET® 7
Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex).
Penumbra is recalling JET 7 Xtra Flex because the catheter may
become susceptible to distal tip damage during use. Distal tip
damage in conjunction with pressurization or contrast injection may
result in potential vessel damage, and subsequent patient injury or
death. Please refer to Penumbra's website at
www.penumbrainc.com/notifications to review the full recall
advisory.
Conference Call and Webcast Information
Penumbra, Inc.
will be hosting a conference call on December 15, 2020 at 2:30 p.m.
PST to discuss this announcement. The conference call can be
accessed live over the phone by dialing (833) 227-5837 for domestic
callers or (647) 689-4064 for international callers (conference id:
7264926), or an audio webcast can be accessed on the "Events"
section under the "Investors" tab of the Company's website at:
www.penumbrainc.com. The webcast will be available on the Company's
website for at least two weeks following the completion of the
call.
About Penumbra
Penumbra, Inc., headquartered in
Alameda, California, is a global
healthcare company focused on innovative therapies. Penumbra
designs, develops, manufactures and markets novel products and has
a broad portfolio that addresses challenging medical conditions in
markets with significant unmet need. Penumbra sells its products to
hospitals and healthcare providers primarily through its direct
sales organization in the United
States, most of Europe,
Canada and Australia, and through distributors in select
international markets. Penumbra, the Penumbra logo and Penumbra JET
are trademarks of Penumbra, Inc. For more information,
visit www.penumbrainc.com.
Forward-Looking Statements
Except for historical
information, certain statements in this press release are
forward-looking in nature and are subject to risks, uncertainties
and assumptions about us. Our business and operations are subject
to a variety of risks and uncertainties and, consequently, actual
results may differ materially from those projected by any
forward-looking statements. Factors that could cause actual results
to differ from those projected include, but are not limited to: the
impact of the COVID-19 pandemic on our business, results of
operations and financial condition; failure to sustain or grow
profitability or generate positive cash flows; failure to
effectively introduce and market new products; delays in product
introductions; significant competition; inability to further
penetrate our current customer base, expand our user base and
increase the frequency of use of our products by our customers;
inability to achieve or maintain satisfactory pricing and margins;
manufacturing difficulties; permanent write-downs or write-offs of
our inventory; product defects or failures; unfavorable outcomes in
clinical trials; inability to maintain our culture as we grow;
fluctuations in foreign currency exchange rates; and potential
adverse regulatory actions. These risks and uncertainties, as well
as others, are discussed in greater detail in our filings with the
Securities and Exchange Commission, including our Annual Report on
Form 10-K for the year ended December 31,
2019 filed with the SEC on February
26, 2020, our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2020 filed with the
SEC on May 7, 2020, our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form
10-Q for the quarter ended September 30,
2020 filed with the SEC on November
2, 2020. There may be additional risks of which we are not
presently aware or that we currently believe are immaterial which
could have an adverse impact on our business. Any
forward-looking statements are based on our current expectations,
estimates and assumptions regarding future events and are
applicable only as of the dates of such statements. We make no
commitment to revise or update any forward-looking statements in
order to reflect events or circumstances that may change.
Contact:
Investor Relations
Penumbra, Inc.
investors@penumbrainc.com
510-995-2461
Media Relations
Betsy
Merryman
Merryman Communications
betsy@merrymancommunications.com
media@penumbrainc.com
310-560-8176
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SOURCE Penumbra, Inc.