Cordis Corp. Announces Recall of Crossover Sheath Introducers

Surgical sheath introducers distributed by Cordis Corporation have been recalled because they may stretch or fracture during use, posing a risk of arterial blockages, internal bleeding, and other serious injuries to patients, the Food and Drug Administration said.

The Crossover Sheath Introducer is a long-coil, reinforced, and kink-resistant device used in arterial and venous procedures that require puncturing the skin to deliver fluids. If the product breaks during use, segments of the device can run through the bloodstream and block blood flow or pose a risk of vessel dissection or perforation, the FDA warned.

So far, the company has received six complaints of the devices malfunctioning during use. While no permanent injuries have been reported, in two cases, additional surgery had to be performed to retrieve broken portions of the sheath from inside the patient, the FDA said.

Select Lot and Catalog Numbers Recalled

The voluntary nationwide recall includes medical devices distributed from August 14, 2009 to September 23, 2009 and the following lot ranges and catalog numbers:

• Lot range: U0000025 through U0000059

• Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S

Cordis Corporation is a worldwide leader in the development and manufacture of interventional vascular technology, the FDA said. The company works with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.

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