Cardiovascular Systems Initiates Voluntary Recall of ViperSheath
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:
o Lot range: S28117 through S29174
o 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.
via Cardiovascular Systems Initiates Voluntary Recall of ViperSheathTM Sheath Introducer.
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on Nov 17 2009. Filed under Recalled Products.
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