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U.S. Department of Health and Human Services

Medical Devices

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Cordis Corporation, CROSSOVER Sheath Introducer

Recall Class: Class I

Date Recall Initiated: October 15, 2009

Product: Cordis CROSSOVER Sheath Introducer

Lot Range Catalog Numbers
U0000025 through U0000059 403545S, 403585S,
403745S, 403785S,
403645S, 403685S

The CROSSOVER Sheath Introducer is a product manufactured by Thomas Medical Products, Inc. and distributed by Cordis Corporation.

The product was manufactured from May 1, 2008 through July 31, 2008 and distributed from August 14, 2009 through September 23, 2009.

Use:

The sheath introducer is the device at the end of the catheter that is used to introduce the catheter into the blood vessel.

Recalling Firm:

Cordis Corporation
14201 North West 60th Street
Miami Lakes, Florida 33014-2802

Reason for Recall:

The sheath may stretch or fracture during use. If the device fractures, the separated segment may potentially cause a blood vessel blockage or result in an opening in the groin area (perforation) where the sheath is used. Removal of these segments will result in procedural delays and may require unplanned surgery to remove a portion of the sheath or to control bleeding. This may result in serious injuries or death.

Public Contact:

Customers with questions may contact Cordis at 1-800-327-7714, 24 hours a day, seven days a week.

For more information, see Useful Links below.

FDA District: Florida

FDA Comments:

Surgeons who have these recalled devices must stop implanting them. If the procedure has been completed successfully using the device, there is no concern.

On October 19, 2009, Cordis Corporation sent a recall letter to its customers that described the affected device, the problem, and actions for customers to take. A company representative has contacted customers to assist in:

  • obtaining signatures
  • FAXing the acknowledgement form to the company
  • collecting and returning all units to the company

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links:

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