Cardiovascular Systems ViperSheath Sheath Introducer

Product:

ViperSheath Sheath Introducer is manufactured by Thomas Medical Products, Inc. and is distributed by Cardiovascular Systems, Inc. (CSI).

These devices were manufactured from March 1, 2009 through September 16, 2009 and distributed from March 19, 2009 though September 17, 2009.

Use:

The device is a long-coiled, reinforced, kink-resistant catheter-like tube (sheath) that helps a physician insert a catheter into a blood vessel.

Recalling Firm:

Thomas Medical Products, Inc.
65 Great Valley Parkway
Malvern, Pennsylvania 19355

Distributor:

Cardiovascular Systems, Inc.
651 Campus Drive
St. Paul, Minnesota 55112

Reason for Recall:

Fractures may occur during use. If this occurs, patients may need unplanned surgery to remove the fragments or to control bleeding.

Public Contact:

Customers with questions may contact Thomas Medical Products, Inc. at 1-866-446-3003, Monday-Friday from 8:30 AM-5:00 PM Eastern Time or Cardiovascular Systems, Inc. at 1-877-274-0360. Customers may also visit CSI’s website at http://www.csi360.com.

For more information, see Useful Links below.

FDA District: Philadelphia

FDA Comments:

On October 22, 2009, Thomas Medical sent a letter to CSI to inform them of the need to recall the product. On November 13, 2009, CSI issued a press release for the recall of the ViperSheath. Both companies are arranging for the return of all products.

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 adverse health consequences 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.