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U.S. Department of Health and Human Services

Safety

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Cordis CROSSOVER Sheath Introducer - Recall

Audience: Interventional radiological healthcare professionals, hospital risk managers

[UPDATED 12/23/2009] Recall classified as Class I

[Posted 10/30/2009] Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids. 

The recall was due to stretching or fracture of the sheath during use. 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. Unplanned open surgery may be required to remove the retained segments or control bleeding.

[12/23/2009 - Recall Notice - FDA]
[10/23/2009 - Press Release - Cordis]