[April 17, 2017] |
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Cardiovascular Systems Initiates Voluntary Recall of Saline Infusion Pump
Cardiovascular Systems, Inc. (CSI (News - Alert)) (Nasdaq: CSII) today announced it has
initiated a voluntary recall of its 7-10014 Saline Infusion Pump. CSI
initiated a customer communication of the recall by letter and informed
customers that they may continue to use the affected Saline Infusion
Pumps until they receive a replacement.
The Saline Infusion Pumps provide saline and lubricant infusion during
orbital atherectomy procedures and electrical power to the orbital
atherectomy device. CSI has determined that electromagnetic interference
present in the hospital environment may cause the Pumps to switch to
standby mode during use, requiring the Pump to be reset prior to
continuing treatment. Restoring Pump operation can result in a temporary
delay in the orbital atherectomy procedure. In coronary artery
procedures, this delay of therapy could present an additional risk of a
temporary, medically reversible injury. However, there have been no
reports of patient injury to date.
The Pumps included in the recall were distributed between April 7, 2015
and April 4, 2017. The company plans to recall and replace approximately
900 units currently in customer inventory. CSI expects to record
approximately $1.5 million of expenses in its third quarter of fiscal
2017 related to the recall and replacement of all affected Saline
Infusion Pumps. The recall and related charge do not have an adverse
effect on third quarter revenue and net loss guidance provided by the
company on January 25, 2017. The company will provide additional
financial updates during its regularly scheduled third quarter earnings
conference call on May 3, 2017.
About Cardiovascular Systems, Inc. Cardiovascular
Systems, Inc., based in St. Paul, inn., is a medical device company
focused on developing and commercializing innovative solutions for
treating vascular and coronary disease. The company's Orbital
Atherectomy Systems treat calcified and fibrotic plaque in arterial
vessels throughout the leg and heart in a few minutes of treatment time,
and address many of the limitations associated with existing surgical,
catheter and pharmacological treatment alternatives. The U.S. FDA
granted the first 510(k) clearance for the use of the Orbital
Atherectomy System in peripheral arteries in August 2007. In October
2013, the company received FDA approval for the Coronary Orbital
Atherectomy System. To date, over 290,000 of CSI's devices have been
sold to leading institutions across the United States.
Safe Harbor Certain statements in this news release are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and are provided under the protection of
the safe harbor for forward-looking statements provided by that Act. For
example, statements in this press release regarding (i) the number of
Saline Infusion Pumps affected by the recall and the company's plans to
replace them; (ii) the timing and amount of expenses associated with the
recall; and (iii) the effect of the recall and the issues with the Pump
on the company's financial results, are forward-looking statements.
These statements involve risks and uncertainties that could cause
results to differ materially from those projected, including, but not
limited to, future actions by the FDA and other regulatory bodies; CSI's
failure to adequately assess the cause and effect of the issues with the
Pump that led to the recall; the ability of CSI to adequately modify the
Pump design in order to prevent this issue from happening in the future;
FDA approval of future designs and versions of the Pump, including
replacements in the recall; the ability of CSI to obtain sufficient
components from suppliers to manufacture replacement Pumps; the ability
of CSI to replace the affected Pumps in a timely and effective manner;
the potential that CSI may subsequently discover additional Pumps
subject to recall; the possibility that this recall could subject CSI to
claims or proceedings that may adversely impact its business and
financial condition; and other factors detailed from time to time in
CSI's SEC (News - Alert) reports, including its most recent annual report on Form 10-K
and subsequent quarterly reports on Form 10-Q. CSI encourages you to
consider all of these risks, uncertainties and other factors carefully
in evaluating the forward-looking statements contained in this release.
As a result of these matters, changes in facts, assumptions not being
realized or other circumstances, CSI's actual results may differ
materially from the expected results discussed in the forward-looking
statements contained in this release. The forward-looking statements
made in this release are made only as of the date of this release, and
CSI undertakes no obligation to update them to reflect subsequent events
or circumstances.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170417005803/en/
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