LAWSUITS NEWS & LEGAL INFORMATION
Defective Crossover Sheath Introducer Recalled by Cordis
Cordis Corporation has issued a nationwide recall of all lots of the CROSSOVER® Sheath Introducer due to complaints about stretching or fracture of the sheath during use.
The CROSSOVER® Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.
In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. The physician may be required to perform unplanned open surgery to remove the retained segments or control bleeding. If a procedure has been completed successfully using the product, there is no concern.
To date, Cordis has received 6 complaints about the CROSSOVER® Sheath Introducer. No permanent patient injuries have been reported. In 2 instances, successful surgical intervention was performed to retrieve a portion of the sheath.
Published on Nov-2-09
The CROSSOVER® Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.
In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. The physician may be required to perform unplanned open surgery to remove the retained segments or control bleeding. If a procedure has been completed successfully using the product, there is no concern.
To date, Cordis has received 6 complaints about the CROSSOVER® Sheath Introducer. No permanent patient injuries have been reported. In 2 instances, successful surgical intervention was performed to retrieve a portion of the sheath.
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If you or a loved one has suffered an adverse health event resulting from exposure to this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.Published on Nov-2-09
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