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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Cardiovascular Systems Initiates Voluntary Recall of ViperSheathTM Sheath Introducer

No Material Effect on CSI Financial Results Is Expected

 

Company Contact:
1-877-274-0360

 

FOR IMMEDIATE RELEASE - November 16, 2009 - ST. PAUL, Minn. – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheathTMSheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.

The ViperSheathTM Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. It is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device.

Thomas Medical initiated this recall due to the possibility of fractures in the device. In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

If a procedure has been completed successfully using this product, no further action needs to be taken. To date, CSI is aware of three instances where a ViperSheathTM Sheath Introducer encountered the issues related to this recall. No permanent patient injuries have been reported. In these instances, successful surgical interventions were performed to retrieve a portion of the sheath. CSI has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact CSI at 1-877-274-0360.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

    • Lot range: S28117 through S29174
    • Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

CSI is working with Thomas Medical, which has apprised the U.S. Food and Drug Administration (FDA) of this action. Any adverse events with the use of this product and/or quality problems should be reported via the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

CSI does not expect the voluntary recall to have a material effect on its financial results. The product accounts for less than one percent of CSI’s current revenue.

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 the recall of the ViperSheath product, CSI's expectation that the ViperSheath recall will not have a material effect on its financial results, and procedures completed using the ViperSheath product, 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, negative reaction to the recall, a decline in the use of the other products CSI manufactures, sells or distributes, litigation or FDA action relating to the recall, CSI's actual financial results, general economic conditions and other factors detailed from time to time in CSI’s SEC 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.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. The company’s Diamondback 360® PAD System treats calcified and fibrotic plaque in arterial vessels throughout the leg, and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD (peripheral arterial disease), and CSI commenced a U.S. product launch in September 2007. Since then, more than 600 hospitals across the United States have adopted the system.

For more information visit the company’s Web site at www.csi360.com.

Contacts:

For Cardiovascular Systems, Inc.  

Product Recall

Roger Hamilton

(651) 259-1645

rhamilton@csi360.com

 

Investor Relations

(651) 259-2800

investorrelations@csi360.com

 

Padilla Speer Beardsley:  

Marian Briggs

(612) 455-1742

mbriggs@psbpr.com

 

Nancy A. Johnson

(612) 455-1745

njohnson@psbpr.com

 

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