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U.S. Department of Health and Human Services

Medical Devices

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Thomas Medical Products Inc., Transseptal Sheath Introducer Kits

Recall Class: Class I

Date Recall Initiated: February 1, 2010

Product:

Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit)

To find all the affected lot and catalog numbers, see the company’s press release under Useful Links below.

These devices were manufactured and distributed from October 1, 2006 through December 27, 2009.

Use: These sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall (septum).

Recalling Firm:

Thomas Medical Products
65 Great Valley Parkway
Malvern, Pennsylvania 19355-1302

Reason for Recall:

During heart procedures, the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart. This could lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death.

Public Contact:

Customers with questions may contact the company at 1-866-466-3003, Monday through Friday, 8:30 AM through 5:00 PM, Eastern Time or by email at tmpinfo@ge.com.

FDA District: Philadelphia

FDA Comments:

On February 1, 2010, the company sent notices to their distributors informing them of the problem and requesting that they stop distributing the device. The company also requested their distributors return all unused devices and inform their subaccounts.

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 adverse health consequences or death.

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

Useful Links: